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Reason: The data are confidential and are available upon reasonable requested after publication of the primary results. Please contact: Niels van der Sangen, n.m.r.vandersangen@amsterdamumumc.nl.

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

dataset
posted on 17.12.2021, 09:29 by N.M.R. van der SangenN.M.R. van der Sangen
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.

Funding

ZonMw (grant number 10140022010007)

History

Retention period

01/01/2037

Research priority area

  • Cardiovascular Diseases