RecruitingPhase 4NCT05491200

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

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


Sponsor

Research Maatschap Cardiologen Rotterdam Zuid

Enrollment

1,656 participants

Start Date

Jul 22, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

After a STEMI heart attack treated with a stent, patients typically take two blood-thinning medications (dual antiplatelet therapy, or DAPT) for 12 months. This study tests whether switching to a single blood thinner (prasugrel alone) after just 30–45 days is as effective but causes less bleeding compared to the full 12-month dual therapy. You may be eligible if: • You had a STEMI (ST-elevation myocardial infarction) treated with a stent (PCI) • You completed the initial 30–45 days of dual antiplatelet therapy without any major events or regimen changes • Your stent was successfully placed (less than 30% residual blockage) • You provided informed consent You may NOT be eligible if: • You are on oral anticoagulation (blood thinners like warfarin) • You have had a stroke or transient ischemic attack in the past 12 months • You have severe liver failure (Child-Pugh C) or severe kidney impairment (creatinine clearance below 30) • You are pregnant, recently gave birth (within 90 days), or breastfeeding • You had an out-of-hospital cardiac arrest (unless from a treatable arrhythmia with full recovery) • You are in cardiogenic shock Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPrasugrel based short DAPT

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

DRUGPrasugrel based standard DAPT

Prasugrel based DAPT for 1 year

DEVICEOCT guided revascularization

OCT guided revascularization of the non-culprit lesions

DEVICEAngio 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

View Full Details on ClinicalTrials.gov

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NCT05491200


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