Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy

  • STATUS
    Recruiting
  • End date
    Jun 1, 2022
  • participants needed
    75
  • sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Updated on 2 March 2021

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.

Details
Condition Non ST Segment Elevation Acute Coronary Syndrome
Treatment Prasugrel 10mg
Clinical Study IdentifierNCT04766437
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Last Modified on2 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Non ST Segment Elevation Acute Coronary Syndrome??
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)
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