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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03252249
Recruitment Status : Active, not recruiting
First Posted : August 17, 2017
Last Update Posted : May 27, 2022
Sponsor:
Collaborator:
British Heart Foundation
Information provided by (Responsible Party):
University of Edinburgh

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Coronary Artery Disease Other: 3 months dual anti-platelet therapy Other: 12 months dual anti-platelet therapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4576 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Duration of Dual Anti-Platelet Therapy in Acute Coronary Syndrome
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 3 months dual anti-platelet therapy
3 months dual anti-platelet therapy is the intervention.
Other: 3 months dual anti-platelet therapy
Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.

Active Comparator: 12 months dual anti-platelet therapy
12 months dual anti-platelet therapy is the intervention.
Other: 12 months dual anti-platelet therapy
Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: Randomisation to 15 months after the end of recruitment ]

Secondary Outcome Measures :
  1. Non-cardiovascular death (Including fatal bleeding) and major non-fatal bleeding [ Time Frame: Randomisation to 15 months after the end of recruitment ]
  2. Non-cardiovascular death (including fatal bleeding) [ Time Frame: Randomisation to 15 months after the end of recruitment ]
  3. Major fatal and non-fatal bleeding [ Time Frame: Randomisation to 15 months after the end of recruitment ]
  4. Hospitalisation for bleeding [ Time Frame: Randomisation to 15 months after the end of recruitment ]
  5. Intracranial haemorrhage [ Time Frame: Randomisation to 15 months after the end of recruitment ]
  6. Gastrointestinal bleeding [ Time Frame: Randomisation to 15 months after the end of recruitment ]
  7. Blood Transfusion [ Time Frame: Randomisation to 15 months after the end of recruitment ]
  8. Haemoglobin (testing and fall) [ Time Frame: Randomisation to 15 months after the end of recruitment ]
  9. Iron Therapy [ Time Frame: Randomisation to 15 months after the end of recruitment ]
  10. Cardiovascular death and non-fatal myocardial infarction [ Time Frame: Randomisation to 15 months after the end of recruitment ]
  11. Cardiovascular mortality (cardiac and non-cardiac) [ Time Frame: Randomisation to 15 months after the end of recruitment ]
  12. Myocardial infarction (fatal and non-fatal) [ Time Frame: Randomisation to 15 months after the end of recruitment ]
  13. Stent Thrombosis [ Time Frame: Randomisation to 15 months after the end of recruitment ]
  14. Coronary revascularisation [ Time Frame: Randomisation to 15 months after the end of recruitment ]
  15. Thrombotic stroke [ Time Frame: Randomisation to 15 months after the end of recruitment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252249


Locations
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United Kingdom
Edinburgh Royal Infirmary
Edinburgh, United Kingdom
Sponsors and Collaborators
University of Edinburgh
British Heart Foundation
Investigators
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Principal Investigator: David Newby University of Edinburgh
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03252249    
Other Study ID Numbers: AC16104
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases