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

NCT06916520 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-03-04

No results posted yet for this study

Summary

Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent-related and non-stent-related ischemic events after percutaneous coronary intervention (PCI). However, this therapy is also associated with a higher risk of bleeding. Given the advances in stent technology and pharmacology, it may be possible to treat patients undergoing PCI with low dose prasugrel as single antiplatelet therapy, regardless of medical history, age or body weight.

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.

Conditions

  • Coronary Arterial Disease (CAD)
  • Percutaneous Coronary Intervention (PCI)

Interventions

DRUG

Prasugrel 5 mg

Prasugrel 5 mg once daily (monotherapy)

DRUG

Dual Antiplatelet (DAPT) Therapy

Dual antiplatelet therapy according to guidelines

Sponsors & Collaborators

  • J.P.S Henriques

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-13
Primary Completion
2026-04-30
Completion
2027-04-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06916520 on ClinicalTrials.gov