Duration of Dual Anti-Platelet Therapy (DUAL-ACS)

University of Edinburgh5,094 enrolled

Overview

Despite substantial evidence supporting the use of dual anti-platelet therapy in patients with acute coronary syndrome, there remains major uncertainty regarding the optimal duration of therapy. Recent evidence suggests that shorter durations of dual anti-platelet therapy are superior because the avoidance of atherothrombotic events is counterbalanced by the greater risks of excess major bleeding with apparent increases in all-cause mortality with longer durations. We here propose an international randomised controlled trial of 18,318 patients with type 1 myocardial infarction allocated to differing durations of dual anti-platelet therapy. We will use electronic health record linkage to track duration of therapy and clinical outcomes in a real-world, real-time, efficient and highly cost-effective trial. This has the potential to define treatment duration, settle a major outstanding international controversy, and influence modern cardiology practice across the world.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

5,094

Conditions

Acute Coronary Syndrome Coronary Artery Disease

3 months dual anti-platelet therapyOTHER

Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.

12 months dual anti-platelet therapyOTHER

Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged ≥18 years * Clinical diagnosis of Type 1 myocardial infarction within 12 weeks * In the opinion of the attending clinician requires dual anti-platelet therapy with aspirin and a P2Y12 receptor antagonist * Resident in the country of recruitment with their unique health identifier * The attending clinician has equipoise regarding the duration of therapy * Provision of informed consent Exclusion Criteria: * Clear indication for specific duration of dual anti-platelet therapy * Type 2 myocardial infarction * Contraindication to aspirin or P2Y12 receptor antagonist * Non-resident in the country of recruitment * Previous recruitment into the trial * Inability or unwilling to give informed consent

Locations (1)

Edinburgh Royal Infirmary

Edinburgh, United Kingdom

Outcomes

Primary Outcomes

Time-to-event: All-cause Mortality

Restricted Mean Survival Time

Time frame: Date of index MI to 15 months

Incidence: All-cause Mortality

Occurrence of event

Time frame: Date of index MI to 15 months