Duration of Dual Anti-Platelet Therapy (DUAL-ACS)
NCT03252249 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5094
Last updated 2026-02-18
Summary
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.
Conditions
- Acute Coronary Syndrome
- Coronary Artery Disease
Interventions
- OTHER
-
3 months dual anti-platelet therapy
Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.
- OTHER
-
12 months dual anti-platelet therapy
Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Sponsors & Collaborators
-
British Heart Foundation
collaborator OTHER -
University of Edinburgh
lead OTHER
Principal Investigators
-
David Newby · University of Edinburgh
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-11
- Primary Completion
- 2023-02-04
- Completion
- 2023-02-04
Countries
- United Kingdom
Study Locations
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