Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy

OPTICA

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 using a potent P2Y12-inhibitor such as prasugrel or ticagrelor. Objective: This study will serve as a pilot to investigate the feasibility and safety of a single antiplatelet strategy with prasugrel or ticagrelor prior to, during and after stent implantation in 75 patients with non-ST segment elevation acute coronary syndrome. Study design: Single-center, 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 or twice daily 90 mg ticagrelor for 12 months preceded by a loading dose of 60 mg prasugrel or 180 mg ticagrelor at least 2 hours prior to percutaneous coronary intervention without concurrent aspirin therapy. Main study endpoint: The primary ischemic endpoints 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.

2021-02-19

2022-09-03

2023-03-03

Completed

Early phase I

75

Inclusion Criteria: * NSTE-ACS diagnosis * 'De novo' coronary lesion(s) eligible for PCI * Written informed consent Exclusion Criteria: * Known allergy or contraindication for prasugrel and ticagrelor 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 * Recent or ongoing therapy with CYP4A4-substrates with a narrow therapeutic index * Pregnant or breastfeeding women at time of enrolment * Participation in another trial with an investigational drug or device (i.e. stent)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm pilot study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 75, 'type': 'ACTUAL'}}

2023-03-06