Trial Outcomes & Findings for Anglo-Scandinavian Cardiac Outcomes Trial: Post Trial Follow-Up Study (NCT NCT01499511)
NCT ID: NCT01499511
Last Updated: 2019-12-03
Results Overview
Number of participants who have died from cardiovascular disease since the end of the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Armstudy
Recruitment status
COMPLETED
Target enrollment
1718 participants
Primary outcome timeframe
16 years
Results posted on
2019-12-03
Participant Flow
Participant milestones
| Measure |
ASCOT Participants Amlodipine
It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.
|
ASCOT Participants Atenolol
It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
|
|---|---|---|
|
Overall Study
STARTED
|
885
|
833
|
|
Overall Study
COMPLETED
|
884
|
833
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
ASCOT Participants Amlodipine
It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.
|
ASCOT Participants Atenolol
It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Anglo-Scandinavian Cardiac Outcomes Trial: Post Trial Follow-Up Study
Baseline characteristics by cohort
| Measure |
ASCOT Participants Amlodipine
n=885 Participants
It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.
|
ASCOT Participants Atenolol
n=833 Participants
It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
|
Total
n=1718 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
|
85 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
173 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
800 Participants
n=99 Participants
|
745 Participants
n=107 Participants
|
1545 Participants
n=206 Participants
|
|
Age, Continuous
|
75 years
n=99 Participants
|
74.5 years
n=107 Participants
|
74.8 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
739 Participants
n=99 Participants
|
720 Participants
n=107 Participants
|
1459 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
259 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
885 participants
n=99 Participants
|
833 participants
n=107 Participants
|
1718 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 16 yearsPopulation: Data not collected
Number of participants who have died from cardiovascular disease since the end of the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Armstudy
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 16 yearsPopulation: 13 participants had missing data
Morbidity of non fatal myocardial infarction after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial with two groups
Outcome measures
| Measure |
ASCOT Participants
n=877 Participants
Participants from the ASCOT study recruited to the participating ASCOT study centres in the United Kingdom.
|
ASCOT Participants Atenolol
n=828 Participants
It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
|
|---|---|---|
|
Number of Participants With Non Fatal Myocardial Infarction
|
35 Participants
|
37 Participants
|
PRIMARY outcome
Timeframe: 16 yearsPopulation: 18 participants had missing data
Non fatal stroke and TIA (Transient Ischaemic Attack) morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial
Outcome measures
| Measure |
ASCOT Participants
n=877 Participants
Participants from the ASCOT study recruited to the participating ASCOT study centres in the United Kingdom.
|
ASCOT Participants Atenolol
n=823 Participants
It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
|
|---|---|---|
|
Number of Participants With Non Fatal Stroke/TIA (Transient Ischaemic Attack)
|
29 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: 16 yearsPopulation: 22 participants had missing data
Diabetes morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial
Outcome measures
| Measure |
ASCOT Participants
n=871 Participants
Participants from the ASCOT study recruited to the participating ASCOT study centres in the United Kingdom.
|
ASCOT Participants Atenolol
n=825 Participants
It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
|
|---|---|---|
|
Number of Participants Who Have Developed Diabetes Since the End of the ASCOT Trial
|
322 Participants
|
325 Participants
|
SECONDARY outcome
Timeframe: 16 yearsPopulation: 24 participants had missing data
Number of participants who have undergone coronary/peripheral re-vascularisation procedures since the end of the ASCOT trial, follow up
Outcome measures
| Measure |
ASCOT Participants
n=872 Participants
Participants from the ASCOT study recruited to the participating ASCOT study centres in the United Kingdom.
|
ASCOT Participants Atenolol
n=822 Participants
It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
|
|---|---|---|
|
Number of Participants Who Have Undergone Coronary/Peripheral Re-vascularisation Procedures Since the End of the ASCOT Trial
|
39 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: 16 yearsPopulation: 18 participants had missing data
Number of participants who have required renal replacement therapy (dialysis or kidney transplant) since the end of the ASCOT trial, follow up
Outcome measures
| Measure |
ASCOT Participants
n=874 Participants
Participants from the ASCOT study recruited to the participating ASCOT study centres in the United Kingdom.
|
ASCOT Participants Atenolol
n=826 Participants
It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
|
|---|---|---|
|
Number of Participants Who Have Required Renal Replacement Therapy (Dialysis or Kidney Transplant) Since the End of the ASCOT Trial
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 16 yearsPopulation: Combined together with 3. primary outcome, it was not possible to differentiate between data collected for TIAs and Non fatal stroke
Outcome measures
Outcome data not reported
Adverse Events
ASCOT Participants Amlodipine
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
ASCOT Participants Atenolol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ASCOT Participants Amlodipine
n=885 participants at risk
Follow up study for amlodipine, no intervention.
|
ASCOT Participants Atenolol
n=833 participants at risk
Follow up study for atenolol, no intervention.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Injuries
|
0.11%
1/885 • Number of events 1 • 16 years
|
0.00%
0/833 • 16 years
|
|
Cardiac disorders
Ischaemic stroke
|
0.11%
1/885 • Number of events 1 • 16 years
|
0.00%
0/833 • 16 years
|
Other adverse events
| Measure |
ASCOT Participants Amlodipine
n=885 participants at risk
Follow up study for amlodipine, no intervention.
|
ASCOT Participants Atenolol
n=833 participants at risk
Follow up study for atenolol, no intervention.
|
|---|---|---|
|
Nervous system disorders
Collapse
|
0.00%
0/885 • 16 years
|
0.12%
1/833 • Number of events 1 • 16 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.11%
1/885 • Number of events 1 • 16 years
|
0.00%
0/833 • 16 years
|
|
Gastrointestinal disorders
Stomach cramps
|
0.11%
1/885 • Number of events 1 • 16 years
|
0.00%
0/833 • 16 years
|
|
Cardiac disorders
High blood pressure
|
0.11%
1/885 • Number of events 1 • 16 years
|
0.00%
0/833 • 16 years
|
|
Nervous system disorders
Alcohol dependence withdrawal
|
0.11%
1/885 • Number of events 1 • 16 years
|
0.00%
0/833 • 16 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place