Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy

Phase 2

Completed

• Conditions: Non ST Segment Elevation Acute Coronary Syndrome
• Interventions: Drug: Prasugrel 10mg; Drug: Ticagrelor 90mg

• Registration Number: NCT04766437
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-18
• Study Start: 2021-02-19
• Study First Submitted QC: 2021-02-21
• Study First Posted: 2021-02-23
• Primary Completion: 2022-09-03
• Status Verified: 2023-03
• Study Completion: 2023-03-03
• Last Update Submitted: 2023-03-03
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• NSTE-ACS diagnosis
• 'De novo' coronary lesion(s) eligible for PCI
• Written informed consent

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prasugrel or ticagrelor monotherapy	Prasugrel 10mg	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.
Prasugrel or ticagrelor monotherapy	Ticagrelor 90mg	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.

Primary Outcome Measures

Name	Time	Method
Primary ischemic endpoint	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	6 months	Number of participants with primary bleeding endpoint defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding

Trial Locations

Locations (1)

Amsterdam UMC, location AMC; 🇳🇱 Amsterdam, Netherlands