Trial Outcomes & Findings for Duration of Dual Anti-Platelet Therapy (DUAL-ACS) (NCT NCT03252249)

NCT ID: NCT03252249

Last Updated: 2026-02-18

Results Overview

Restricted Mean Survival Time

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 5094 participants
• Primary outcome timeframe: Date of index MI to 15 months
• Results posted on: 2026-02-18

Participant Flow

All randomised participants in database.

42 participants were excluded from the ITT population following randomisation, those who subsequently became ineligible after a diagnosis other than Type 1 myocardial infarction (MI) and withdrawn from the trial were excluded.

Participant milestones

Measure	3 Months Dual Anti-platelet Therapy 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Overall Study STARTED	2526	2526
Overall Study COMPLETED	2526	2526
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Missing data

Baseline characteristics by cohort

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.	Total n=5052 Participants Total of all reporting groups
Age, Continuous	63.4 years STANDARD_DEVIATION 10.9 • n=2522 Participants • Missing data	63.4 years STANDARD_DEVIATION 10.8 • n=2522 Participants • Missing data	63.4 years STANDARD_DEVIATION 10.8 • n=5044 Participants • Missing data
Sex/Gender, Customized Sex; Female, Male · Female	684 Participants n=2526 Participants	685 Participants n=2526 Participants	1369 Participants n=5052 Participants
Sex/Gender, Customized Sex; Female, Male · Male	1838 Participants n=2526 Participants	1837 Participants n=2526 Participants	3675 Participants n=5052 Participants
Sex/Gender, Customized Sex; Female, Male · Not available	4 Participants n=2526 Participants	4 Participants n=2526 Participants	8 Participants n=5052 Participants
Race/Ethnicity, Customized White	285 Participants n=2526 Participants	284 Participants n=2526 Participants	569 Participants n=5052 Participants
Race/Ethnicity, Customized Mixed	1 Participants n=2526 Participants	2 Participants n=2526 Participants	3 Participants n=5052 Participants
Race/Ethnicity, Customized Asian	12 Participants n=2526 Participants	18 Participants n=2526 Participants	30 Participants n=5052 Participants
Race/Ethnicity, Customized Black	2 Participants n=2526 Participants	1 Participants n=2526 Participants	3 Participants n=5052 Participants
Race/Ethnicity, Customized Other	7 Participants n=2526 Participants	2 Participants n=2526 Participants	9 Participants n=5052 Participants
Race/Ethnicity, Customized Not stated or not known	50 Participants n=2526 Participants	54 Participants n=2526 Participants	104 Participants n=5052 Participants
Race/Ethnicity, Customized Missing	5 Participants n=2526 Participants	1 Participants n=2526 Participants	6 Participants n=5052 Participants
Race/Ethnicity, Customized Data not collected for Scotland or New Zealand	2164 Participants n=2526 Participants	2164 Participants n=2526 Participants	4328 Participants n=5052 Participants
Region of Enrollment United Kingdom	2265 participants n=2526 Participants	2269 participants n=2526 Participants	4534 participants n=5052 Participants
Region of Enrollment New Zealand	261 participants n=2526 Participants	257 participants n=2526 Participants	518 participants n=5052 Participants
Social Deprivation Quintile 1 (most deprived)	455 Participants n=2526 Participants	393 Participants n=2526 Participants	848 Participants n=5052 Participants
Social Deprivation Quintile 2	484 Participants n=2526 Participants	511 Participants n=2526 Participants	995 Participants n=5052 Participants
Social Deprivation Quintile 3	505 Participants n=2526 Participants	499 Participants n=2526 Participants	1004 Participants n=5052 Participants
Social Deprivation Quintile 4	467 Participants n=2526 Participants	489 Participants n=2526 Participants	956 Participants n=5052 Participants
Social Deprivation Quintile 5 (least deprived)	447 Participants n=2526 Participants	473 Participants n=2526 Participants	920 Participants n=5052 Participants
Social Deprivation Not recorded	154 Participants n=2526 Participants	145 Participants n=2526 Participants	299 Participants n=5052 Participants
Social Deprivation Missing	14 Participants n=2526 Participants	16 Participants n=2526 Participants	30 Participants n=5052 Participants
Clinical Management at Randomisation CABG surgery	81 Participants n=2526 Participants	80 Participants n=2526 Participants	161 Participants n=5052 Participants
Clinical Management at Randomisation Drug eluting stent	1364 Participants n=2526 Participants	1366 Participants n=2526 Participants	2730 Participants n=5052 Participants
Clinical Management at Randomisation Bare metal stent	13 Participants n=2526 Participants	14 Participants n=2526 Participants	27 Participants n=5052 Participants
Clinical Management at Randomisation Medical management	169 Participants n=2526 Participants	164 Participants n=2526 Participants	333 Participants n=5052 Participants
Clinical Management at Randomisation Conservative	69 Participants n=2526 Participants	67 Participants n=2526 Participants	136 Participants n=5052 Participants
Clinical Management at Randomisation ICA planned	830 Participants n=2526 Participants	835 Participants n=2526 Participants	1665 Participants n=5052 Participants

PRIMARY outcome

Timeframe: Date of index MI to 15 months

Population: Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Restricted Mean Survival Time

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Time-to-event: All-cause Mortality	447.337 days Standard Error 1.0542	445.196 days Standard Error 1.1741

PRIMARY outcome

Timeframe: Date of index MI to 15 months

Population: Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Occurrence of event

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Incidence: All-cause Mortality	68 Participants	87 Participants

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Restricted Mean Survival Time

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding	442.881 days Standard Error 1.2908	440.736 days Standard Error 1.3565

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Occurrence of event

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Incidence: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding	104 participants	127 participants

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Restricted Mean Survival Time

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding)	452.453 days Standard Error 0.5873	452.593 days Standard Error 0.5285

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Occurrence of event

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Incidence: Non-cardiovascular Death (Including Fatal Bleeding)	27 participants	29 participants

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Restricted Mean Survival Time

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Time-to-event: Major Fatal and Non-fatal Bleeding	445.227 days Standard Error 1.1719	442.790 days Standard Error 1.2794

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Occurrence of event

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Incidence: Major Fatal and Non-fatal Bleeding	80 participants	102 participants

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Restricted Mean Survival Time

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Time-to-event: Gastrointestinal Bleeding	449.967 days Standard Error 0.8887	450.562 days Standard Error 0.7774

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Occurrence of event

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Incidence: Gastrointestinal Bleeding	36 Participants	38 Participants

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Restricted Mean Survival Time

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Time-to-event: Cardiovascular Death and Non-fatal Myocardial Infarction	422.876 days Standard Error 2.1559	424.670 days Standard Error 2.1010

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Occurrence of event

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Incidence: Cardiovascular Death and Non-fatal Myocardial Infarction	236 Participants	226 Participants

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Restricted Mean Survival Time

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Time-to-event: Cardiovascular Mortality (Cardiac and Non-cardiac)	449.943 days Standard Error 0.8891	447.897 days Standard Error 1.0372

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Occurrence of event

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Incidence: Cardiovascular Mortality (Cardiac and Non-cardiac)	40 Participants	56 Participants

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Restricted Mean Survival Time

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Time-to-event: Myocardial Infarction (Fatal and Non-fatal)	424.471 days Standard Error 2.1157	427.444 days Standard Error 2.0181

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Occurrence of event

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Incidence: Myocardial Infarction (Fatal and Non-fatal)	221 Participants	203 Participants

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Occurrence of event

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Incidence: Intracranial Haemorrhage	0 Participants	10 Participants

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Restricted Mean Survival Time

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Time-to-event: Coronary Revascularisation	414.488 days Standard Error 2.3733	417.081 days Standard Error 2.3383

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Occurrence of event

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Incidence: Coronary Revascularisation	286 Participants	259 Participants

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Restricted Mean Survival Time

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Time-to-event: Stent Thrombosis	450.566 days Standard Error 0.8329	450.026 days Standard Error 0.9228

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Occurrence of event

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Incidence: Stent Thrombosis	34 Participants	32 Participants

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Restricted Mean Survival Time

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Time-to-event: Thrombotic Stroke	453.711 days Standard Error 0.4353	454.244 days Standard Error 0.3519

SECONDARY outcome

Timeframe: Date of MI to 15 months

Population: The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention.

Occurrence of event

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2526 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2526 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Incidence: Thrombotic Stroke	13 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Date of MI to 15 months

Population: Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. As specified in the protocol, other endpoints will be collected where possible and therefore there is missing data.

Restricted Mean Survival Time

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2265 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2269 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Time-to-event: Iron Therapy	439.175 days Standard Error 1.5407	439.749 days Standard Error 1.4840

OTHER_PRE_SPECIFIED outcome

Timeframe: Date of MI to 15 months

Population: The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. As specified in the protocol, other endpoints will be collected where possible and therefore there is missing data.

Occurrence of event

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2265 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2269 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Incidence: Iron Therapy	116 Participants	122 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Date of MI to 15 months

Population: Intention to Treat Population. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. As specified in the protocol, other endpoints will be collected where possible and therefore there is missing data.

Restricted Mean Survival Time

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2164 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2164 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Time-to-event: Blood Transfusion	430.118 days Standard Error 2.1292	430.346 days Standard Error 2.1049

OTHER_PRE_SPECIFIED outcome

Timeframe: Date of MI to 15 months

Population: The intention to treat (ITT) principle. Patients were analysed according to their allocated intervention, irrespective of whether the patient's actual management complied with the allocated intervention. As specified in the protocol, other endpoints will be collected where possible and therefore there is missing data.

Occurrence of event

Outcome measures

Measure	3 Months Dual Anti-platelet Therapy n=2164 Participants 3 months dual anti-platelet therapy. 3 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.	12 Months Dual Anti-platelet Therapy n=2164 Participants 12 months dual anti-platelet therapy. 12 months dual anti-platelet therapy: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Incidence: Blood Transfusion	138 Participants	140 Participants

Adverse Events

3 Months Dual Anti-platelet Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 68 deaths

12 Months Dual Anti-platelet Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 87 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor David Newby

University of Edinburgh

Phone: 0131 242 6515

Email: D.E.Newby@ed.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place