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RECRUITING
NCT05491200
PHASE4

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

Sponsor: Research Maatschap Cardiologen Rotterdam Zuid

View on ClinicalTrials.gov

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.

Official title: COMPARE STEMI ONE- Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients Treated With OCT-guided vs aNgio-guided completE Revascularization

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

1656

Start Date

2022-07-22

Completion Date

2028-08-01

Last Updated

2025-08-06

Healthy Volunteers

No

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

Locations (26)

Imelda Bonheiden

Bonheiden, Belgium

AZ St.Jan

Bruges, Belgium

ZOL Genk

Genk, Belgium

UZ Leuven

Leuven, Belgium

AZ Delta

Roeselare, Belgium

FN BRNO

Brno, Czechia

Masaryk Hospital Usti nad Labem -

Hradec Králové, Czechia

Charles University Hospital

Prague, Czechia

Asklepios Klinik Bad Oldesloe

Bad Oldesloe, Germany

Segeberger Kliniken

Bad Segeberg, Germany

University hospital Dresden

Dresden, Germany

Ospedale Papa Giovanni XXIII

Bergamo, Italy

University of Ferrara

Ferrara, Italy

University San Martino

Genova, Italy

Centro Cardiologico Monzino IRCCS

Milan, Italy

University Federico II

Naples, Italy

University Gemelli

Roma, Italy

Albert Schweitzer ziekenhuis

Dordrecht, Netherlands

Catherina ziekenhuis

Eindhoven, Netherlands

RadboudUMC

Nijmegen, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

Maasstadziekenhuis

Rotterdam, Netherlands

Haga hospital

The Hague, Netherlands

Institute for CVD Dedinje

Belgrade, Serbia

University clinical center of Serbia

Belgrade, Serbia

Institute for CVD Vojvodine

Kamenitz, Serbia