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

January 28, 2026 updated by: University of Edinburgh

Duration of Dual Anti-Platelet Therapy in Acute Coronary Syndrome

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5094

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 3 months dual anti-platelet therapy
3 months dual anti-platelet therapy.
Other: 3 months dual anti-platelet therapy
Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.
Active Comparator: 12 months dual anti-platelet therapy
12 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-to-event: All-cause Mortality
Time Frame: Date of index MI to 15 months
Restricted Mean Survival Time
Date of index MI to 15 months
Incidence: All-cause Mortality
Time Frame: Date of index MI to 15 months
Occurrence of event
Date of index MI to 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Date of MI to 15 months
Incidence: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding
Time Frame: Date of MI to 15 months
Occurrence of event
Date of MI to 15 months
Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding)
Time Frame: Date of MI to 15 months
Restricted Mean Survival Time
Date of MI to 15 months
Incidence: Non-cardiovascular Death (Including Fatal Bleeding)
Time Frame: Date of MI to 15 months
Occurrence of event
Date of MI to 15 months
Time-to-event: Major Fatal and Non-fatal Bleeding
Time Frame: Date of MI to 15 months
Restricted Mean Survival Time
Date of MI to 15 months
Incidence: Major Fatal and Non-fatal Bleeding
Time Frame: Date of MI to 15 months
Occurrence of event
Date of MI to 15 months
Time-to-event: Gastrointestinal Bleeding
Time Frame: Date of MI to 15 months
Restricted Mean Survival Time
Date of MI to 15 months
Incidence: Gastrointestinal Bleeding
Time Frame: Date of MI to 15 months
Occurrence of event
Date of MI to 15 months
Time-to-event: Cardiovascular Death and Non-fatal Myocardial Infarction
Time Frame: Date of MI to 15 months
Restricted Mean Survival Time
Date of MI to 15 months
Incidence: Cardiovascular Death and Non-fatal Myocardial Infarction
Time Frame: Date of MI to 15 months
Occurrence of event
Date of MI to 15 months
Time-to-event: Cardiovascular Mortality (Cardiac and Non-cardiac)
Time Frame: Date of MI to 15 months
Restricted Mean Survival Time
Date of MI to 15 months
Incidence: Cardiovascular Mortality (Cardiac and Non-cardiac)
Time Frame: Date of MI to 15 months
Occurrence of event
Date of MI to 15 months
Time-to-event: Myocardial Infarction (Fatal and Non-fatal)
Time Frame: Date of MI to 15 months
Restricted Mean Survival Time
Date of MI to 15 months
Incidence: Myocardial Infarction (Fatal and Non-fatal)
Time Frame: Date of MI to 15 months
Occurrence of event
Date of MI to 15 months
Incidence: Intracranial Haemorrhage
Time Frame: Date of MI to 15 months
Occurrence of event
Date of MI to 15 months
Time-to-event: Coronary Revascularisation
Time Frame: Date of MI to 15 months
Restricted Mean Survival Time
Date of MI to 15 months
Incidence: Coronary Revascularisation
Time Frame: Date of MI to 15 months
Occurrence of event
Date of MI to 15 months
Time-to-event: Stent Thrombosis
Time Frame: Date of MI to 15 months
Restricted Mean Survival Time
Date of MI to 15 months
Incidence: Stent Thrombosis
Time Frame: Date of MI to 15 months
Occurrence of event
Date of MI to 15 months
Time-to-event: Thrombotic Stroke
Time Frame: Date of MI to 15 months
Restricted Mean Survival Time
Date of MI to 15 months
Incidence: Thrombotic Stroke
Time Frame: Date of MI to 15 months
Occurrence of event
Date of MI to 15 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-to-event: Iron Therapy
Time Frame: Date of MI to 15 months
Restricted Mean Survival Time
Date of MI to 15 months
Incidence: Iron Therapy
Time Frame: Date of MI to 15 months
Occurrence of event
Date of MI to 15 months
Time-to-event: Blood Transfusion
Time Frame: Date of MI to 15 months
Restricted Mean Survival Time
Date of MI to 15 months
Incidence: Blood Transfusion
Time Frame: Date of MI to 15 months
Occurrence of event
Date of MI to 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

British Heart Foundation

Investigators

  • Principal Investigator: David Newby, University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2018

Primary Completion (Actual)

February 4, 2023

Study Completion (Actual)

February 4, 2023

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 14, 2017

First Posted (Actual)

August 17, 2017

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC16104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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