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
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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