Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Treatments: Prasugrel Hydrochloride

Criteria

Inclusion Criteria:

• NSTE-ACS diagnosis

• 'De novo' coronary lesion(s) eligible for PCI

• Written informed consent

Exclusion Criteria:

• Known allergy or contraindication for prasugrel use.

• Concurrent use of oral anticoagulants

• Overwriting indication for DAPT

• Planned surgical intervention within 12 months of planned revascularization

• PCI of left main disease, chronic total occlusion, bifurcation lesion requiring two-stent treatment, saphenous or arterial graft lesion, severely calcified lesions

• Recent or ongoing strong CYP3A4 inhibitor or inducer therapy

• Pregnant or breastfeeding women at time of enrolment

• Participation in another trial with an investigational drug or device (i.e. stent)