Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients

NCT05491200 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1656

Last updated 2025-08-06

No results posted yet for this study

Summary

The study is a multi-centre, Open-label, Randomized Controlled, 1:1 trial comparing Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus standard DAPT regimen in STEMI patients in terms of safety and efficacy endpoints.

In the subgroup of STEMI patients with MVD, a sub-randomization will allow a comparison between a complete revascularization OCT-guided versus complete revascularization angiography-guided stent in terms of efficacy and safety endpoints.

Conditions

  • ST Elevated Myocardial Infarction
  • Dual Antiplatelet Therapy

Interventions

DRUG

Prasugrel based short DAPT

Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus

DRUG

Prasugrel based standard DAPT

Prasugrel based DAPT for 1 year

DEVICE

OCT guided revascularization

OCT guided revascularization of the non-culprit lesions

DEVICE

Angio guided revascularization

Angio guided revascularization of the non-culprit lesions

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY
  • Research Maatschap Cardiologen Rotterdam Zuid

    lead OTHER

Principal Investigators

  • Valeria Paradies, MD, PhD · Research Maatschap Cardiologen Rotterdam Zuid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-22
Primary Completion
2026-08-01
Completion
2028-08-01

Countries

  • Belgium
  • Czechia
  • Germany
  • Italy
  • Netherlands
  • Serbia

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 NCT05491200 on ClinicalTrials.gov