Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 3, 2022

Interventions

  • Drug: Prasugrel 10mg
    • 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 without concurrent aspirin therapy.
  • Drug: Ticagrelor 90mg
    • Twice daily 90 mg ticagrelor for 12 months preceded by a loading dose of 180 mg ticagrelor at least 2 hours prior to percutaneous coronary intervention without concurrent aspirin therapy.

Arms, Groups and Cohorts

  • Experimental: Prasugrel or ticagrelor monotherapy
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Primary ischemic endpoint
    • Time Frame: 6 months
    • Number of participants with primary ischemic endpoint defined as composite of all-cause mortality, myocardial infarction, Academic Research Consortium defined stent thrombosis and ischemic stroke
  • Primary bleeding endpoint
    • Time Frame: 6 months
    • Number of participants with primary bleeding endpoint defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA)
  • Provider of Information About this Clinical Study
    • Principal Investigator: J.P.S Henriques, Principal Investigator – Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA)

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