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Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Objective: Assess the feasibility and safety of a single antiplatelet strategy with a reduced dose of prasugrel 5 mg after PCI in acute and chronic coronary syndrome patients (ACS and CCS). Study design: Open-label, single-centre, randomized controlled trial. Study population: Patients undergoing successful PCI due to acute or chronic coronary syndrome. Intervention: A once-daily reduced dose of 5 mg prasugrel for 6 months in CCS patients and for 12 months in ACS patients, preceded by a loading dose of 60 mg prasugrel after PCI, administered without concomitant use of aspirin. Main study parameters/endpoints: The primary endpoint is Net Adverse Clinical Events (NACE), a composite of all-cause death, myocardial infarction, definite stent thrombosis, ischemic stroke, clinically relevant non-major bleeding or major bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Acute Coronary Syndrome

• Chronic Coronary Syndrome

• Successful PCI

Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Time Frame
Start Date: 2025-11-13
Estimated Completion Date: 2027-04
Participants
Target number of participants: 300
Treatments
Experimental: Intervention Arm
Prasugrel low-dose monotherapy
Active_comparator: Control Arm
Dual antiplatelet therapy
Sponsors
Leads: J.P.S Henriques

This content was sourced from clinicaltrials.gov

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