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

Primary Purpose

Acute Coronary Syndrome, Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
3 months dual anti-platelet therapy
12 months dual anti-platelet therapy
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged ≥18 years
  • Clinical diagnosis of Type 1 myocardial infarction
  • 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

Sites / Locations

  • Edinburgh Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

3 months dual anti-platelet therapy

12 months dual anti-platelet therapy

Arm Description

3 months dual anti-platelet therapy is the intervention.

12 months dual anti-platelet therapy is the intervention.

Outcomes

Primary Outcome Measures

All-cause mortality

Secondary Outcome Measures

Non-cardiovascular death (Including fatal bleeding) and major non-fatal bleeding
Non-cardiovascular death (including fatal bleeding)
Major fatal and non-fatal bleeding
Hospitalisation for bleeding
Intracranial haemorrhage
Gastrointestinal bleeding
Blood Transfusion
Haemoglobin (testing and fall)
Iron Therapy
Cardiovascular death and non-fatal myocardial infarction
Cardiovascular mortality (cardiac and non-cardiac)
Myocardial infarction (fatal and non-fatal)
Stent Thrombosis
Coronary revascularisation
Thrombotic stroke

Full Information

First Posted
August 9, 2017
Last Updated
May 10, 2023
Sponsor
University of Edinburgh
Collaborators
British Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03252249
Brief Title
Duration of Dual Anti-Platelet Therapy (DUAL-ACS)
Official Title
Duration of Dual Anti-Platelet Therapy in Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 26, 2018 (Actual)
Primary Completion Date
February 4, 2023 (Actual)
Study Completion Date
February 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
British Heart Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4576 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3 months dual anti-platelet therapy
Arm Type
Active Comparator
Arm Description
3 months dual anti-platelet therapy is the intervention.
Arm Title
12 months dual anti-platelet therapy
Arm Type
Active Comparator
Arm Description
12 months dual anti-platelet therapy is the intervention.
Intervention Type
Other
Intervention Name(s)
3 months dual anti-platelet therapy
Intervention Description
Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.
Intervention Type
Other
Intervention Name(s)
12 months dual anti-platelet therapy
Intervention Description
Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
Primary Outcome Measure Information:
Title
All-cause mortality
Time Frame
Randomisation to 15 months after the end of recruitment
Secondary Outcome Measure Information:
Title
Non-cardiovascular death (Including fatal bleeding) and major non-fatal bleeding
Time Frame
Randomisation to 15 months after the end of recruitment
Title
Non-cardiovascular death (including fatal bleeding)
Time Frame
Randomisation to 15 months after the end of recruitment
Title
Major fatal and non-fatal bleeding
Time Frame
Randomisation to 15 months after the end of recruitment
Title
Hospitalisation for bleeding
Time Frame
Randomisation to 15 months after the end of recruitment
Title
Intracranial haemorrhage
Time Frame
Randomisation to 15 months after the end of recruitment
Title
Gastrointestinal bleeding
Time Frame
Randomisation to 15 months after the end of recruitment
Title
Blood Transfusion
Time Frame
Randomisation to 15 months after the end of recruitment
Title
Haemoglobin (testing and fall)
Time Frame
Randomisation to 15 months after the end of recruitment
Title
Iron Therapy
Time Frame
Randomisation to 15 months after the end of recruitment
Title
Cardiovascular death and non-fatal myocardial infarction
Time Frame
Randomisation to 15 months after the end of recruitment
Title
Cardiovascular mortality (cardiac and non-cardiac)
Time Frame
Randomisation to 15 months after the end of recruitment
Title
Myocardial infarction (fatal and non-fatal)
Time Frame
Randomisation to 15 months after the end of recruitment
Title
Stent Thrombosis
Time Frame
Randomisation to 15 months after the end of recruitment
Title
Coronary revascularisation
Time Frame
Randomisation to 15 months after the end of recruitment
Title
Thrombotic stroke
Time Frame
Randomisation to 15 months after the end of recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged ≥18 years Clinical diagnosis of Type 1 myocardial infarction 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Newby
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edinburgh Royal Infirmary
City
Edinburgh
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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