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Completed

NCT Number: NCT03252249

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

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.

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Key information

Conditions

Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Edinburgh Royal Infirmary

Edinburgh, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3 months dual anti-platelet therapy

Other

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

12 months dual anti-platelet therapy

Other

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

Primary outcomes

  1. Time-to-event: All-cause Mortality

    Time frame: Date of index MI to 15 months

    Restricted Mean Survival Time

  2. Incidence: All-cause Mortality

    Time frame: Date of index MI to 15 months

    Occurrence of event

Secondary outcomes

  1. Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding

    Time frame: Date of MI to 15 months

    Restricted Mean Survival Time

  2. Incidence: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding

    Time frame: Date of MI to 15 months

    Occurrence of event

  3. Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding)

    Time frame: Date of MI to 15 months

    Restricted Mean Survival Time

  4. Incidence: Non-cardiovascular Death (Including Fatal Bleeding)

    Time frame: Date of MI to 15 months

    Occurrence of event

  5. Time-to-event: Major Fatal and Non-fatal Bleeding

    Time frame: Date of MI to 15 months

    Restricted Mean Survival Time

  6. Incidence: Major Fatal and Non-fatal Bleeding

    Time frame: Date of MI to 15 months

    Occurrence of event

  7. Time-to-event: Gastrointestinal Bleeding

    Time frame: Date of MI to 15 months

    Restricted Mean Survival Time

  8. Incidence: Gastrointestinal Bleeding

    Time frame: Date of MI to 15 months

    Occurrence of event

  9. Time-to-event: Cardiovascular Death and Non-fatal Myocardial Infarction

    Time frame: Date of MI to 15 months

    Restricted Mean Survival Time

  10. Incidence: Cardiovascular Death and Non-fatal Myocardial Infarction

    Time frame: Date of MI to 15 months

    Occurrence of event

  11. Time-to-event: Cardiovascular Mortality (Cardiac and Non-cardiac)

    Time frame: Date of MI to 15 months

    Restricted Mean Survival Time

  12. Incidence: Cardiovascular Mortality (Cardiac and Non-cardiac)

    Time frame: Date of MI to 15 months

    Occurrence of event

  13. Time-to-event: Myocardial Infarction (Fatal and Non-fatal)

    Time frame: Date of MI to 15 months

    Restricted Mean Survival Time

  14. Incidence: Myocardial Infarction (Fatal and Non-fatal)

    Time frame: Date of MI to 15 months

    Occurrence of event

  15. Incidence: Intracranial Haemorrhage

    Time frame: Date of MI to 15 months

    Occurrence of event

  16. Time-to-event: Coronary Revascularisation

    Time frame: Date of MI to 15 months

    Restricted Mean Survival Time

  17. Incidence: Coronary Revascularisation

    Time frame: Date of MI to 15 months

    Occurrence of event

  18. Time-to-event: Stent Thrombosis

    Time frame: Date of MI to 15 months

    Restricted Mean Survival Time

  19. Incidence: Stent Thrombosis

    Time frame: Date of MI to 15 months

    Occurrence of event

  20. Time-to-event: Thrombotic Stroke

    Time frame: Date of MI to 15 months

    Restricted Mean Survival Time

  21. Incidence: Thrombotic Stroke

    Time frame: Date of MI to 15 months

    Occurrence of event

Other outcomes

  1. Time-to-event: Iron Therapy

    Time frame: Date of MI to 15 months

    Restricted Mean Survival Time

  2. Incidence: Iron Therapy

    Time frame: Date of MI to 15 months

    Occurrence of event

  3. Time-to-event: Blood Transfusion

    Time frame: Date of MI to 15 months

    Restricted Mean Survival Time

  4. Incidence: Blood Transfusion

    Time frame: Date of MI to 15 months

    Occurrence of event

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • British Heart Foundation

Registry information

Official study title

Duration of Dual Anti-Platelet Therapy in Acute Coronary Syndrome

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2017
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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