Percutaneous Coronary Intervention (PCI) Clinical Trials

Clinical trials related to Percutaneous Coronary Intervention (PCI) Procedure

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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