Clinical trial NCT03252249: Duration of Dual Anti-Platelet Therapy (DUAL-ACS)
Official title: Duration of Dual Anti-Platelet Therapy in Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Coronary Artery Disease
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2017-08-17
Enrollment: 4576
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: All-cause mortality
timeFrame: Randomisation to 15 months after the end of recruitment
Secondary outcomes:
measure: Non-cardiovascular death (Including fatal bleeding) and major non-fatal bleeding
timeFrame: Randomisation to 15 months after the end of recruitment
measure: Non-cardiovascular death (including fatal bleeding)
timeFrame: Randomisation to 15 months after the end of recruitment
measure: Major fatal and non-fatal bleeding
timeFrame: Randomisation to 15 months after the end of recruitment
measure: Hospitalisation for bleeding
timeFrame: Randomisation to 15 months after the end of recruitment
measure: Intracranial haemorrhage
timeFrame: Randomisation to 15 months after the end of recruitment
measure: Gastrointestinal bleeding
timeFrame: Randomisation to 15 months after the end of recruitment
measure: Cardiovascular death and non-fatal myocardial infarction
timeFrame: Randomisation to 15 months after the end of recruitment
measure: Cardiovascular mortality (cardiac and non-cardiac)
timeFrame: Randomisation to 15 months after the end of recruitment
measure: Myocardial infarction (fatal and non-fatal)
timeFrame: Randomisation to 15 months after the end of recruitment
measure: Stent Thrombosis
timeFrame: Randomisation to 15 months after the end of recruitment
measure: Coronary revascularisation
timeFrame: Randomisation to 15 months after the end of recruitment
measure: Thrombotic stroke
timeFrame: Randomisation to 15 months after the end of recruitment
Other outcomes:
measure: Blood Transfusion
timeFrame: Randomisation to 15 months after the end of recruitment
measure: Haemoglobin
timeFrame: Randomisation to 15 months after the end of recruitment
measure: Iron Therapy
timeFrame: Randomisation to 15 months after the end of recruitment
Locations:
city: Edinburgh
country: United Kingdom
facility: Edinburgh Royal Infirmary
Study officials:
affiliation: University of Edinburgh
name: David Newby
role: PRINCIPAL_INVESTIGATOR
References: