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

University of Edinburgh

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Acute Coronary Syndrome

Treatments: Other: 3 months dual anti-platelet therapy; Other: 12 months dual anti-platelet therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03252249

AC16104

Details and patient eligibility

About

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.

Enrollment: 5,094 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,094 participants in 2 patient groups

3 months dual anti-platelet therapy

Active Comparator group

Description:

3 months dual anti-platelet therapy.

Treatment:

Other: 3 months dual anti-platelet therapy

12 months dual anti-platelet therapy

Active Comparator group

Description:

12 months dual anti-platelet therapy.

Treatment:

Other: 12 months dual anti-platelet therapy