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

Coronary Artery Disease Clinical Trial

Official title:

Duration of Dual Anti-Platelet Therapy in Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03252249
• Other study ID #: AC16104
• Status: Completed
• Phase: Phase 4
• Start date: April 26, 2018
• Est. completion date: February 4, 2023

Study information

• Verified date: November 2023
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4576
• Est. completion date: February 4, 2023
• Est. primary completion date: February 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Syndrome

Intervention

Other:
• 3 months dual anti-platelet therapy
Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.
• 12 months dual anti-platelet therapy
Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.

Locations

Country	Name	City	State
United Kingdom	Edinburgh Royal Infirmary	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood Transfusion		Randomisation to 15 months after the end of recruitment
Other	Haemoglobin		Randomisation to 15 months after the end of recruitment
Other	Iron Therapy		Randomisation to 15 months after the end of recruitment
Primary	All-cause mortality		Randomisation to 15 months after the end of recruitment
Secondary	Non-cardiovascular death (Including fatal bleeding) and major non-fatal bleeding		Randomisation to 15 months after the end of recruitment
Secondary	Non-cardiovascular death (including fatal bleeding)		Randomisation to 15 months after the end of recruitment
Secondary	Major fatal and non-fatal bleeding		Randomisation to 15 months after the end of recruitment
Secondary	Hospitalisation for bleeding		Randomisation to 15 months after the end of recruitment
Secondary	Intracranial haemorrhage		Randomisation to 15 months after the end of recruitment
Secondary	Gastrointestinal bleeding		Randomisation to 15 months after the end of recruitment
Secondary	Cardiovascular death and non-fatal myocardial infarction		Randomisation to 15 months after the end of recruitment
Secondary	Cardiovascular mortality (cardiac and non-cardiac)		Randomisation to 15 months after the end of recruitment
Secondary	Myocardial infarction (fatal and non-fatal)		Randomisation to 15 months after the end of recruitment
Secondary	Stent Thrombosis		Randomisation to 15 months after the end of recruitment
Secondary	Coronary revascularisation		Randomisation to 15 months after the end of recruitment
Secondary	Thrombotic stroke		Randomisation to 15 months after the end of recruitment