Phase 4
N=5,052
Duration of Dual Anti-Platelet Therapy (DUAL-ACS)
Acute Coronary Syndrome · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT03252249 ↗Enrolled (actual)
5,052
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Time-to-event: All-cause Mortality — 447.337; 445.196 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 3 months dual anti-platelet therapy (Other); 12 months dual anti-platelet therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Edinburgh
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-to-event: All-cause Mortality |
447.337; 445.196 | — |
| PRIMARY Incidence: All-cause Mortality |
68; 87 | 0.1232 |
| SECONDARY Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding |
442.881; 440.736 | — |
| SECONDARY Incidence: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding |
104; 127 | 0.1220 |
| SECONDARY Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding) |
452.453; 452.593 | — |
| SECONDARY Incidence: Non-cardiovascular Death (Including Fatal Bleeding) |
27; 29 | 0.7789 |
| SECONDARY Time-to-event: Major Fatal and Non-fatal Bleeding |
445.227; 442.790 | — |
| SECONDARY Incidence: Major Fatal and Non-fatal Bleeding |
80; 102 | 0.0977 |
| SECONDARY Time-to-event: Gastrointestinal Bleeding |
449.967; 450.562 | — |
| SECONDARY Incidence: Gastrointestinal Bleeding |
36; 38 | 0.8208 |
| SECONDARY Time-to-event: Cardiovascular Death and Non-fatal Myocardial Infarction |
422.876; 424.670 | — |
| SECONDARY Incidence: Cardiovascular Death and Non-fatal Myocardial Infarction |
236; 226 | 0.6158 |
| SECONDARY Time-to-event: Cardiovascular Mortality (Cardiac and Non-cardiac) |
449.943; 447.897 | — |
| SECONDARY Incidence: Cardiovascular Mortality (Cardiac and Non-cardiac) |
40; 56 | 0.1020 |
| SECONDARY Time-to-event: Myocardial Infarction (Fatal and Non-fatal) |
424.471; 427.444 | — |
| SECONDARY Incidence: Myocardial Infarction (Fatal and Non-fatal) |
221; 203 | 0.3623 |
| SECONDARY Incidence: Intracranial Haemorrhage |
0; 10 | — |
| SECONDARY Time-to-event: Coronary Revascularisation |
414.488; 417.081 | — |
| SECONDARY Incidence: Coronary Revascularisation |
286; 259 | 0.2324 |
| SECONDARY Time-to-event: Stent Thrombosis |
450.566; 450.026 | — |
| SECONDARY Incidence: Stent Thrombosis |
34; 32 | 0.8104 |
| SECONDARY Time-to-event: Thrombotic Stroke |
453.711; 454.244 | — |
| SECONDARY Incidence: Thrombotic Stroke |
13; 7 | 0.1875 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03252249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.