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Phase 4 N=5,052 Randomized Treatment

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

Acute Coronary Syndrome · Coronary Artery Disease

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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