NCT03252249

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

Completed Phase 4 Results posted Last updated 18 February 2026

What this trial tests

Phase 4 trial testing 3 months dual anti-platelet therapy in Acute Coronary Syndrome in 5,094 participants. Completed in 4 February 2023.

Timeline

11 December 2018

Primary endpoint
4 February 2023

4 February 2023

Quick facts

Lead sponsor	University of Edinburgh
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	5,094
Start date	11 December 2018
Primary completion	4 February 2023
Estimated completion	4 February 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• 3 months dual anti-platelet therapy
• 12 months dual anti-platelet therapy

Conditions studied

• Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

University of Edinburgh

Who can join

18 and older, any sex, with Acute Coronary Syndrome or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time-to-event: All-cause Mortality Primary · Date of index MI to 15 months

Restricted Mean Survival Time

Group	Value	95% CI
3 Months Dual Anti-platelet Therapy	447.337	± 1.0542
12 Months Dual Anti-platelet Therapy	445.196	± 1.1741

Incidence: All-cause Mortality Primary · Date of index MI to 15 months

Occurrence of event

Group	Value	95% CI
3 Months Dual Anti-platelet Therapy	68
12 Months Dual Anti-platelet Therapy	87

Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding Secondary · Date of MI to 15 months

Restricted Mean Survival Time

Group	Value	95% CI
3 Months Dual Anti-platelet Therapy	442.881	± 1.2908
12 Months Dual Anti-platelet Therapy	440.736	± 1.3565

Incidence: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding Secondary · Date of MI to 15 months

Occurrence of event

Group	Value	95% CI
3 Months Dual Anti-platelet Therapy	104
12 Months Dual Anti-platelet Therapy	127

Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding) Secondary · Date of MI to 15 months

Restricted Mean Survival Time

Group	Value	95% CI
3 Months Dual Anti-platelet Therapy	452.453	± 0.5873
12 Months Dual Anti-platelet Therapy	452.593	± 0.5285

Incidence: Non-cardiovascular Death (Including Fatal Bleeding) Secondary · Date of MI to 15 months

Occurrence of event

Group	Value	95% CI
3 Months Dual Anti-platelet Therapy	27
12 Months Dual Anti-platelet Therapy	29

Time-to-event: Major Fatal and Non-fatal Bleeding Secondary · Date of MI to 15 months

Restricted Mean Survival Time

Group	Value	95% CI
3 Months Dual Anti-platelet Therapy	445.227	± 1.1719
12 Months Dual Anti-platelet Therapy	442.790	± 1.2794

Incidence: Major Fatal and Non-fatal Bleeding Secondary · Date of MI to 15 months

Occurrence of event

Group	Value	95% CI
3 Months Dual Anti-platelet Therapy	80
12 Months Dual Anti-platelet Therapy	102

Time-to-event: Gastrointestinal Bleeding Secondary · Date of MI to 15 months

Restricted Mean Survival Time

Group	Value	95% CI
3 Months Dual Anti-platelet Therapy	449.967	± 0.8887
12 Months Dual Anti-platelet Therapy	450.562	± 0.7774

Incidence: Gastrointestinal Bleeding Secondary · Date of MI to 15 months

Occurrence of event

Group	Value	95% CI
3 Months Dual Anti-platelet Therapy	36
12 Months Dual Anti-platelet Therapy	38

Time-to-event: Cardiovascular Death and Non-fatal Myocardial Infarction Secondary · Date of MI to 15 months

Restricted Mean Survival Time

Group	Value	95% CI
3 Months Dual Anti-platelet Therapy	422.876	± 2.1559
12 Months Dual Anti-platelet Therapy	424.670	± 2.1010

Incidence: Cardiovascular Death and Non-fatal Myocardial Infarction Secondary · Date of MI to 15 months

Occurrence of event

Group	Value	95% CI
3 Months Dual Anti-platelet Therapy	236
12 Months Dual Anti-platelet Therapy	226

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antiplatelet therapy after percutaneous coronary intervention.
   Angiolillo DJ, Galli M, Collet JP, Kastrati A, et al · · 2022 · cited 199× · PMID 35354550 · DOI 10.4244/eij-d-21-00904
2. De-escalation of antiplatelet therapy in acute coronary syndromes: Why, how and when?
   Galli M, Angiolillo DJ. · · 2022 · cited 27× · PMID 36093167 · DOI 10.3389/fcvm.2022.975969
3. Pooled Analysis of Bleeding, Major Adverse Cardiovascular Events, and All-Cause Mortality in Clinical Trials of Time-Constrained Dual-Antiplatelet Therapy After Percutaneous Coronary Intervention.
   McClure JD, Ramsay JC, Berry C. · · 2020 · cited 7× · PMID 32779497 · DOI 10.1161/jaha.120.017109
4. Duration of dual antiplatelet therapy and stability of coronary heart disease: a 60 000-patient meta-analysis of randomised controlled trials.
   Bularga A, Meah MN, Doudesis D, Shah ASV, et al · · 2021 · cited 5× · PMID 34341097 · DOI 10.1136/openhrt-2021-001707
5. Antiplatelet Monotherapies for Long-Term Secondary Prevention Following Percutaneous Coronary Intervention.
   Laudani C, Giacoppo D, Greco A, Ortega-Paz L, et al · · 2025 · cited 2× · PMID 40807157 · DOI 10.3390/jcm14155536
6. Reduction or de-escalation of dual antiplatelet therapy intensity or duration in patients with acute coronary syndromes undergoing percutaneous coronary intervention: A mini-review.
   Farag M, Jeyalan V, Ferreiro JL, Jeong YH, et al · · 2022 · cited 2× · PMID 36337887 · DOI 10.3389/fcvm.2022.1018649