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

NCT ID: NCT03252249

Last Updated: 2026-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 5094 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-11
• Study Completion Date: 2023-02-04

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3 months dual anti-platelet therapy

3 months dual anti-platelet therapy.

Group Type: ACTIVE_COMPARATOR

3 months dual anti-platelet therapy

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

12 months dual anti-platelet therapy

Intervention Type: OTHER

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

Interventions

3 months dual anti-platelet therapy

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

Intervention Type: OTHER

12 months dual anti-platelet therapy

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

British Heart Foundation

OTHER

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Newby

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

Edinburgh Royal Infirmary

Edinburgh, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

AC16104

Identifier Type: -

Identifier Source: org_study_id