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

NCT03252249 | Completed Phase 4 Results DMC

• 1 other identifier: AC16104
• Study Type: interventional
• Target: 5,094
• Locations: 1 country
• Sites: 1

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

Coronary Artery Disease; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

• Time-to-event: All-cause Mortality

  Restricted Mean Survival Time

  Date of index MI to 15 months

• Incidence: All-cause Mortality

  Occurrence of event

  Date of index MI to 15 months

Secondary Outcomes (21)

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

  Date of MI to 15 months

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

  Date of MI to 15 months

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

  Date of MI to 15 months

• Incidence: Non-cardiovascular Death (Including Fatal Bleeding)

  Date of MI to 15 months

• Time-to-event: Major Fatal and Non-fatal Bleeding

  Date of MI to 15 months

Other Outcomes (4)

• Time-to-event: Iron Therapy

  Date of MI to 15 months

• Incidence: Iron Therapy

  Date of MI to 15 months

• Time-to-event: Blood Transfusion

  Date of MI to 15 months

Study Arms (2)

3 months dual anti-platelet therapy

ACTIVE COMPARATOR

3 months dual anti-platelet therapy.

Other: 3 months dual anti-platelet therapy

12 months dual anti-platelet therapy

ACTIVE COMPARATOR

12 months dual anti-platelet therapy.

Other: 12 months dual anti-platelet therapy

Interventions

3 months dual anti-platelet therapy OTHER

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

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.

12 months dual anti-platelet therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• British Heart Foundation: collaborator

Study Sites (1)

Edinburgh Royal Infirmary

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease

Interventions

Dual Anti-Platelet Therapy

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Limitations and Caveats

The major limitation is that early trial termination meant the target sample size was not achieved, leaving an underpowered trial which was unable to address its primary endpoint. The recruitment suspension due to COVID-19, and the subsequent delays in re-opening of the study sites and lack of staff capacity significantly affected recruitment.

Results Point of Contact

• Title: Professor David Newby
• Organization: University of Edinburgh

D.E.Newby@ed.ac.uk

0131 242 6515

Study Officials

• David Newby

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 17, 2017
• Study Start: December 11, 2018
• Primary Completion: February 4, 2023
• Study Completion: February 4, 2023
• Last Updated: February 18, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)