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Clinical Trial 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 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 net clinical adverse events and 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 planned for 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 parameters/endpoints: The primary net adverse clinical endpoint is defined as the composite of all-cause death, myocardial infarction, stroke and Bleeding Academic Research Consortium type 3 or 5 bleeding at 12 months. 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05125276
Study type Interventional
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact
Status Not yet recruiting
Phase Phase 4
Start date March 2022
Completion date March 2025

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