Duration of Dual Anti-Platelet Therapy (DUAL-ACS)
- Conditions
- Acute Coronary SyndromeCoronary Artery Disease
- Interventions
- Other: 3 months dual anti-platelet therapyOther: 12 months dual anti-platelet therapy
- Registration Number
- NCT03252249
- Lead Sponsor
- University of Edinburgh
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4576
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 months dual anti-platelet therapy 3 months dual anti-platelet therapy 3 months dual anti-platelet therapy. 12 months dual anti-platelet therapy 12 months dual anti-platelet therapy 12 months dual anti-platelet therapy.
- Primary Outcome Measures
Name Time Method All-cause mortality Randomisation to 15 months after the end of recruitment
- Secondary Outcome Measures
Name Time Method Non-cardiovascular death (Including fatal bleeding) and major non-fatal bleeding Randomisation to 15 months after the end of recruitment Stent Thrombosis Randomisation to 15 months after the end of recruitment Hospitalisation for 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 Intracranial haemorrhage Randomisation to 15 months after the end of recruitment Cardiovascular mortality (cardiac and non-cardiac) 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 Myocardial infarction (fatal and non-fatal) Randomisation to 15 months after the end of recruitment Non-cardiovascular death (including fatal bleeding) 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
Trial Locations
- Locations (1)
Edinburgh Royal Infirmary
🇬🇧Edinburgh, United Kingdom