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

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: Coronary Artery Disease; Acute Coronary Syndrome
• Intervention / Treatment: Other: 3 months dual anti-platelet therapy; Other: 12 months dual anti-platelet therapy

• Study Type: Interventional
• Enrollment (Actual): 4576
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom
    • Edinburgh Royal Infirmary

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Time Frame
All-cause mortality	Randomisation to 15 months after the end of recruitment

Secondary Outcome Measures

Outcome Measure	Time Frame
Non-cardiovascular death (Including fatal bleeding) and major non-fatal bleeding	Randomisation to 15 months after the end of recruitment
Non-cardiovascular death (including fatal bleeding)	Randomisation to 15 months after the end of recruitment
Major fatal and non-fatal bleeding	Randomisation to 15 months after the end of recruitment
Hospitalisation for bleeding	Randomisation to 15 months after the end of recruitment
Intracranial haemorrhage	Randomisation to 15 months after the end of recruitment
Gastrointestinal bleeding	Randomisation to 15 months after the end of recruitment
Cardiovascular death and non-fatal myocardial infarction	Randomisation to 15 months after the end of recruitment
Cardiovascular mortality (cardiac and non-cardiac)	Randomisation to 15 months after the end of recruitment
Myocardial infarction (fatal and non-fatal)	Randomisation to 15 months after the end of recruitment
Stent Thrombosis	Randomisation to 15 months after the end of recruitment
Coronary revascularisation	Randomisation to 15 months after the end of recruitment
Thrombotic stroke	Randomisation to 15 months after the end of recruitment

Other Outcome Measures

Outcome Measure	Time Frame
Blood Transfusion	Randomisation to 15 months after the end of recruitment
Iron Therapy	Randomisation to 15 months after the end of recruitment
Haemoglobin	Randomisation to 15 months after the end of recruitment

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: British Heart Foundation
• Investigators: Principal Investigator: David Newby, University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 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 (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Coronary Disease; Coronary Artery Disease; Syndrome; Acute Coronary Syndrome
• 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