Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients (LEGACY)
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|ClinicalTrials.gov Identifier: NCT05125276|
Recruitment Status : Recruiting
First Posted : November 18, 2021
Last Update Posted : July 19, 2023
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3090 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Experimental: Interventional arm
Drug: No aspirin
Active Comparator: Control arm
Aspirin (75-100 mg once daily)
75-100 mg once daily
- 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
- Ischemic endpoint [ Time Frame: 12 months ]The primary ischemic endpoint at 12 months is the composite of all-cause mortality, myocardial infarction and stroke
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
|Amsterdam UMC, location AMC||Recruiting|
|Contact: José P.S. Henriques, MD, PhD 020-5662857 firstname.lastname@example.org|
|Amsterdam UMC, location VUmc||Recruiting|
|Contact: Yolande Appelman, MD, PhD 020-5662857 email@example.com|