Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
Rationale: Dual antiplatelet therapy (DAPT), 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 using a potent P2Y12-
inhibitor such as prasugrel.
Objective: This study will serve as a pilot to investigate the feasibility and safety of a
single antiplatelet strategy with prasugrel prior to, during and after stent implantation in
75 patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS).
Study design: Single arm pilot study with a stopping rule based on the occurrence of definite
stent thrombosis
Study population: Patients presenting with non-ST segment elevation acute coronary syndrome
and (a) 'de novo' lesion(s) treated with new generation drug-eluting stent(s) with adequate
reduction of platelet reactivity according to platelet function testing with VerifyNow and
optimal stenting result adjudicated by optical coherence tomography or coronary angiography.
Intervention: Once daily 10 mg prasugrel for 12 months preceded by a loading dose of 60 mg
prasugrel at least 2 hours prior to percutaneous coronary intervention (PCI) without
concurrent aspirin therapy.
Main study endpoint: The primary ischemic endpoint is the composite of all-cause mortality,
myocardial infarction, Academic Research Consortium defined stent thrombosis and ischemic
stroke at 6 months after percutaneous coronary intervention. The primary bleeding outcome is
major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5
bleeding at 6 months after percutaneous coronary intervention.
Phase:
Phase 2
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)