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

Study Overview
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Brief Summary
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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.

Official Title
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Duration of Dual Anti-Platelet Therapy in Acute Coronary Syndrome

Conditions
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Acute Coronary Syndrome, Coronary Artery Disease

Intervention / Treatment
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* Other: 3 months dual anti-platelet therapy
* Other: 12 months dual anti-platelet therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | Randomisation to 15 months after the end of recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |