Trial Outcomes & Findings for Clopidogrel Monotherapy in Patients With High Bleeding Risk (NCT NCT05223335)
NCT ID: NCT05223335
Last Updated: 2024-02-21
Results Overview
The number of participants to experience ischemic events as defined as cardiac deaths, spontaneous myocardial infarctions (MIs) and stent thrombosis after percutaneous intervention (PCI).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
98 participants
Primary outcome timeframe
Through study completion, approximately 90 days.
Results posted on
2024-02-21
Participant Flow
Participant milestones
| Measure |
Genotype-Guided Therapy
Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYP2C19\*2 or\*3 LOF allele carrier were given prasugrel or ticagrelor monotherapy.
Prasugrel: 60 mg bolus then 10 mg daily
Tricagrelor: 180 mg bolus then 90 mg twice daily
|
Conventional Therapy
Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19\*2 or\*3 LOF allele non-carriers continued with clopidogrel monotherapy.
Clopidogrel: 75 mg/day
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
69
|
|
Overall Study
COMPLETED
|
29
|
69
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clopidogrel Monotherapy in Patients With High Bleeding Risk
Baseline characteristics by cohort
| Measure |
Genotype-Guided Therapy
n=29 Participants
Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYP2C19\*2 or\*3 LOF allele carrier were given prasugrel or ticagrelor monotherapy.
Prasugrel: 60 mg bolus then 10 mg daily
Tricagrelor: 180 mg bolus then 90 mg twice daily
|
Conventional Therapy
n=69 Participants
Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19\*2 or\*3 LOF allele non-carriers continued with clopidogrel monotherapy.
Clopidogrel: 75 mg/day
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.8 years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
75.3 years
STANDARD_DEVIATION 10.8 • n=107 Participants
|
74.6 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=99 Participants
|
69 participants
n=107 Participants
|
98 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through study completion, approximately 90 days.The number of participants to experience ischemic events as defined as cardiac deaths, spontaneous myocardial infarctions (MIs) and stent thrombosis after percutaneous intervention (PCI).
Outcome measures
| Measure |
Genotype-Guided Therapy
n=29 Participants
Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYP2C19\*2 or\*3 LOF allele carrier were given prasugrel or ticagrelor monotherapy.
Prasugrel: 60 mg bolus then 10 mg daily
Tricagrelor: 180 mg bolus then 90 mg twice daily
|
Conventional Therapy
n=69 Participants
Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19\*2 or\*3 LOF allele non-carriers continued with clopidogrel monotherapy.
Clopidogrel: 75 mg/day
|
|---|---|---|
|
Ischemic Risk Post-PCI in High Bleed Risk Patients With Genotype-guided Single Antiplatelet Therapy
|
0 Participants
|
1 Participants
|
Adverse Events
Genotype-Guided Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Therapy
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Genotype-Guided Therapy
n=29 participants at risk
Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYP2C19\*2 or\*3 LOF allele carrier were given prasugrel or ticagrelor monotherapy.
Prasugrel: 60 mg bolus then 10 mg daily
Tricagrelor: 180 mg bolus then 90 mg twice daily
|
Conventional Therapy
n=69 participants at risk
Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19\*2 or\*3 LOF allele non-carriers continued with clopidogrel monotherapy.
Clopidogrel: 75 mg/day
|
|---|---|---|
|
Vascular disorders
Possible Stent Thrombosis
|
0.00%
0/29 • Adverse Events were collected from baseline to end of study, approximately 90 days
|
1.4%
1/69 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 90 days
|
Other adverse events
| Measure |
Genotype-Guided Therapy
n=29 participants at risk
Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYP2C19\*2 or\*3 LOF allele carrier were given prasugrel or ticagrelor monotherapy.
Prasugrel: 60 mg bolus then 10 mg daily
Tricagrelor: 180 mg bolus then 90 mg twice daily
|
Conventional Therapy
n=69 participants at risk
Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19\*2 or\*3 LOF allele non-carriers continued with clopidogrel monotherapy.
Clopidogrel: 75 mg/day
|
|---|---|---|
|
Vascular disorders
BARC 3 bleeding event
|
0.00%
0/29 • Adverse Events were collected from baseline to end of study, approximately 90 days
|
4.3%
3/69 • Number of events 3 • Adverse Events were collected from baseline to end of study, approximately 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place