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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5094

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Edinburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
British Heart Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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