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Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients (LEGACY)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05125276
Recruitment Status : Recruiting
First Posted : November 18, 2021
Last Update Posted : July 19, 2023
Sponsor:
Information provided by (Responsible Party):
J.P.S Henriques, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
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Brief Summary:

Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent thrombosis, myocardial infarction and stroke after coronary stent implantation. Inevitably, it is also associated with a higher risk of (major) bleeding. Given the advances in stent properties, stenting implantation technique and pharmacology, it may be possible to treat patients with a single antiplatelet strategy by completely omitting aspirin.

Objective: This study will assess whether omitting aspirin reduces the rate of major or minor bleeding while remaining non-inferior to the current standard of care with regards to ischemic events in patients with non-ST segment elevation acute coronary syndrome.

Study design: Open-label, multicentre randomized controlled trial.

Study population: Adult patients presenting with non-ST segment elevation acute coronary syndrome undergoing percutaneous coronary intervention.

Intervention: In the intervention group aspirin will be completely omitted from the antiplatelet regimen in the 12 months following PCI.

Main study endpoints: The primary bleeding endpoint is major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding at 12 months. The primary ischemic endpoint is ischemic events defined as the composite of all-cause death, myocardial infarction and stroke at 12 months.


Condition or disease Intervention/treatment Phase
Non ST Segment Elevation Acute Coronary Syndrome Drug: No aspirin Drug: Aspirin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3090 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients
Actual Study Start Date : May 13, 2022
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Aspirin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Interventional arm
No aspirin
 Drug: No aspirin
No aspirin
Active Comparator: Control arm
Aspirin (75-100 mg once daily)
 Drug: Aspirin
75-100 mg once daily


Outcome Measures
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Primary Outcome Measures :
  1. Bleeding endpoint [ Time Frame: 12 months ]
    The primary bleeding endpoint at 12 months is major or minor bleeding defined as BARC type 2, 3 or 5 bleeding

  2. Ischemic endpoint [ Time Frame: 12 months ]
    The primary ischemic endpoint at 12 months is the composite of all-cause mortality, myocardial infarction and stroke


Eligibility Criteria
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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:

  • Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina)
  • Successful PCI (according to the treating physician)

Exclusion Criteria:

  • Known allergy or contraindication for aspirin or all commercially available P2Y12-inhibitors (i.e. ticagrelor, prasugrel and clopidogrel)
  • Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation)
  • Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS)
  • Planned surgical intervention within 12 months of PCI
  • Pregnant or breastfeeding women at time of enrolment
  • Participation in another trial with an investigational drug or device
Contacts and Locations
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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): NCT05125276


Locations
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Netherlands
Amsterdam UMC, location AMC Recruiting
Amsterdam, Netherlands
Contact: José P.S. Henriques, MD, PhD    020-5662857    legacy@amsterdamumc.nl   
Amsterdam UMC, location VUmc Recruiting
Amsterdam, Netherlands
Contact: Yolande Appelman, MD, PhD    020-5662857    legacy@amsterdamumc.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information
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Responsible Party: J.P.S Henriques, Prof. Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT05125276    
Other Study ID Numbers: NL79129.018.21
First Posted: November 18, 2021    Key Record Dates
Last Update Posted: July 19, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics