Trial Outcomes & Findings for GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation (NCT NCT01813435)
NCT ID: NCT01813435
Last Updated: 2022-03-15
Results Overview
Number of Participants with a composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
15991 participants
Primary outcome timeframe
2 year
Results posted on
2022-03-15
Participant Flow
12 participants of the experimental group withdrew consent or objected to use further use of data 11 participants of the reference group withdrew consent or objected to use further use of data
Participant milestones
| Measure |
Experimental Treatment Strategy
All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.
Dosage and frequency:
Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
|
Reference Treatment Strategy
Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.
Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.
Dosage and frequency:
Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for
|
|---|---|---|
|
Overall Study
STARTED
|
7980
|
7988
|
|
Overall Study
COMPLETED
|
5810
|
6981
|
|
Overall Study
NOT COMPLETED
|
2170
|
1007
|
Reasons for withdrawal
| Measure |
Experimental Treatment Strategy
All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.
Dosage and frequency:
Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
|
Reference Treatment Strategy
Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.
Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.
Dosage and frequency:
Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for
|
|---|---|---|
|
Overall Study
did not finish experimental regimen
|
1902
|
770
|
|
Overall Study
Lost to Follow-up
|
268
|
237
|
Baseline Characteristics
these are the numbers analysed for primary endpoint.
Baseline characteristics by cohort
| Measure |
Experimental Treatment Strategy
n=7980 Participants
All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.
Dosage and frequency:
Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
|
Reference Treatment Strategy
n=7988 Participants
Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.
Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.
Dosage and frequency:
Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for
|
Total
n=15968 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3949 Participants
n=99 Participants
|
3928 Participants
n=107 Participants
|
7877 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4031 Participants
n=99 Participants
|
4060 Participants
n=107 Participants
|
8091 Participants
n=206 Participants
|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
64.6 years
STANDARD_DEVIATION 10.3 • n=107 Participants
|
64.6 years
STANDARD_DEVIATION 10.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1865 Participants
n=99 Participants • these are the numbers analysed for primary endpoint.
|
1849 Participants
n=107 Participants • these are the numbers analysed for primary endpoint.
|
3714 Participants
n=206 Participants • these are the numbers analysed for primary endpoint.
|
|
Sex: Female, Male
Male
|
6115 Participants
n=99 Participants • these are the numbers analysed for primary endpoint.
|
6139 Participants
n=107 Participants • these are the numbers analysed for primary endpoint.
|
12254 Participants
n=206 Participants • these are the numbers analysed for primary endpoint.
|
|
Region of Enrollment
Singapore
|
71 participants
n=99 Participants
|
71 participants
n=107 Participants
|
142 participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
264 participants
n=99 Participants
|
263 participants
n=107 Participants
|
527 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
854 participants
n=99 Participants
|
859 participants
n=107 Participants
|
1713 participants
n=206 Participants
|
|
Region of Enrollment
Portugal
|
56 participants
n=99 Participants
|
57 participants
n=107 Participants
|
113 participants
n=206 Participants
|
|
Region of Enrollment
Switzerland
|
352 participants
n=99 Participants
|
353 participants
n=107 Participants
|
705 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
475 participants
n=99 Participants
|
476 participants
n=107 Participants
|
951 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
84 participants
n=99 Participants
|
86 participants
n=107 Participants
|
170 participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
335 participants
n=99 Participants
|
337 participants
n=107 Participants
|
672 participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
579 participants
n=99 Participants
|
580 participants
n=107 Participants
|
1159 participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
1094 participants
n=99 Participants
|
1091 participants
n=107 Participants
|
2185 participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
126 participants
n=99 Participants
|
122 participants
n=107 Participants
|
248 participants
n=206 Participants
|
|
Region of Enrollment
Denmark
|
66 participants
n=99 Participants
|
65 participants
n=107 Participants
|
131 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
768 participants
n=99 Participants
|
764 participants
n=107 Participants
|
1532 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
790 participants
n=99 Participants
|
788 participants
n=107 Participants
|
1578 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
41 participants
n=99 Participants
|
42 participants
n=107 Participants
|
83 participants
n=206 Participants
|
|
Region of Enrollment
Bulgaria
|
470 participants
n=99 Participants
|
473 participants
n=107 Participants
|
943 participants
n=206 Participants
|
|
Region of Enrollment
France
|
426 participants
n=99 Participants
|
423 participants
n=107 Participants
|
849 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
1129 participants
n=99 Participants
|
1138 participants
n=107 Participants
|
2267 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 yearPopulation: Shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded. Data were censored 730 days after index percutaneous coronary intervention.
Number of Participants with a composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation.
Outcome measures
| Measure |
Experimental Treatment Strategy
n=7980 Participants
All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.
Dosage and frequency:
Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
|
Reference Treatment Strategy
n=7988 Participants
Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.
Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.
Dosage and frequency:
Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for
|
|---|---|---|
|
Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)
|
304 Participants
|
349 Participants
|
SECONDARY outcome
Timeframe: 2-yearOutcome measures
| Measure |
Experimental Treatment Strategy
n=7980 Participants
All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.
Dosage and frequency:
Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
|
Reference Treatment Strategy
n=7988 Participants
Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.
Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.
Dosage and frequency:
Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for
|
|---|---|---|
|
Number of Participants With All-cause Mortality
|
224 Participants
|
253 Participants
|
SECONDARY outcome
Timeframe: 2 yearOutcome measures
| Measure |
Experimental Treatment Strategy
n=7980 Participants
All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.
Dosage and frequency:
Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
|
Reference Treatment Strategy
n=7988 Participants
Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.
Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.
Dosage and frequency:
Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for
|
|---|---|---|
|
Number of Participants With Myocardial Infarction
|
248 Participants
|
250 Participants
|
SECONDARY outcome
Timeframe: 2-yearOutcome measures
| Measure |
Experimental Treatment Strategy
n=7980 Participants
All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.
Dosage and frequency:
Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
|
Reference Treatment Strategy
n=7988 Participants
Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.
Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.
Dosage and frequency:
Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for
|
|---|---|---|
|
Number of Participants With New Q-wave Myocardial Infarction
|
83 Participants
|
103 Participants
|
SECONDARY outcome
Timeframe: 2-yearshown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded
Outcome measures
| Measure |
Experimental Treatment Strategy
n=7980 Participants
All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.
Dosage and frequency:
Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
|
Reference Treatment Strategy
n=7988 Participants
Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.
Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.
Dosage and frequency:
Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for
|
|---|---|---|
|
Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction
|
362 Participants
|
416 Participants
|
SECONDARY outcome
Timeframe: 2 yearOutcome measures
| Measure |
Experimental Treatment Strategy
n=7980 Participants
All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.
Dosage and frequency:
Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
|
Reference Treatment Strategy
n=7988 Participants
Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.
Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.
Dosage and frequency:
Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for
|
|---|---|---|
|
Number of Participants With a Stroke
|
80 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: 2 yearOutcome measures
| Measure |
Experimental Treatment Strategy
n=7980 Participants
All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.
Dosage and frequency:
Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
|
Reference Treatment Strategy
n=7988 Participants
Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.
Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.
Dosage and frequency:
Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for
|
|---|---|---|
|
Number of Participants With a Myocardial Revascularisation
|
739 Participants
|
793 Participants
|
SECONDARY outcome
Timeframe: 2 yearOutcome measures
| Measure |
Experimental Treatment Strategy
n=7980 Participants
All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.
Dosage and frequency:
Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
|
Reference Treatment Strategy
n=7988 Participants
Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.
Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.
Dosage and frequency:
Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for
|
|---|---|---|
|
Number of Participants With a Definite Stent Thrombosis
|
64 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: 2 yearBARC definition. We only considered BARC 3 or 5 for this secondary safety endpoint. Type 3: Clinical, laboratory, and/or imaging evidence of bleeding with: * Type 3a: * Overt bleeding + Hb drop of 3 to \< 5 g/dL (provided Hb drop is related to bleed) * Any transfusion with overt bleeding * Type 3b: * Overt bleeding + Hb drop ≥5 g/dL (provided Hb drop is related to bleed) * Cardiac tamponade * Bleeding requiring surgical intervention (excluding dental/nasal/skin/haemorrhoid) * Bleeding requiring intravenous vasoactive agents * Type 3c: * Intracranial haemorrhage (does not include microbleeds or haemorrhagic transformation, does include intraspinal) * Subcategories confirmed by autopsy or imaging or lumbar puncture * Intraocular bleed compromising vision. Type 5: Fatal bleeding * Type 5a: • Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious * Type 5b: * Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation
Outcome measures
| Measure |
Experimental Treatment Strategy
n=7980 Participants
All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.
Dosage and frequency:
Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
|
Reference Treatment Strategy
n=7988 Participants
Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.
Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.
Dosage and frequency:
Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for
|
|---|---|---|
|
Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding
|
163 Participants
|
169 Participants
|
Adverse Events
Experimental Treatment Strategy
Serious events: 1459 serious events
Other events: 0 other events
Deaths: 224 deaths
Reference Treatment Strategy
Serious events: 1543 serious events
Other events: 0 other events
Deaths: 253 deaths
Serious adverse events
| Measure |
Experimental Treatment Strategy
n=7980 participants at risk
All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.
Dosage and frequency:
Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
|
Reference Treatment Strategy
n=7988 participants at risk
Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.
Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.
Dosage and frequency:
Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd
Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for
|
|---|---|---|
|
Cardiac disorders
new Q-wave MI
|
1.0%
83/7980 • monitored for 2 years
|
1.3%
103/7988 • monitored for 2 years
|
|
Cardiac disorders
MI
|
3.1%
248/7980 • monitored for 2 years
|
3.1%
250/7988 • monitored for 2 years
|
|
Vascular disorders
stroke
|
2.0%
162/7980 • monitored for 2 years
|
2.1%
164/7988 • monitored for 2 years
|
|
Vascular disorders
revascularisation
|
9.3%
739/7980 • monitored for 2 years
|
9.9%
793/7988 • monitored for 2 years
|
|
Vascular disorders
definite stent thrombosis
|
0.80%
64/7980 • monitored for 2 years
|
0.80%
64/7988 • monitored for 2 years
|
|
Vascular disorders
BARC 3 or 5 bleeding
|
2.0%
163/7980 • monitored for 2 years
|
2.1%
169/7988 • monitored for 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Pascal Vranckx
Jessa Ziekenhuis, Hasselt, Belgium
Phone: +32 11 30 9589
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place