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

Recruiting now · Phase 4

Conditions studied: ST Elevated Myocardial Infarction, Dual Antiplatelet Therapy

In brief

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.

Key facts

Study ID

NCT05491200

Run by

Research Maatschap Cardiologen Rotterdam Zuid

People needed

1656

Starts

2022-07-22

Expected to finish

2029-08-01

Last updated by the study team

2026-07-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligibility at index procedure
• All STEMI patients who are planned to be treated with PCI:
• ST segment elevation myocardial infarction
• Chest discomfort suggestive of cardiac ischemia ≥20 min at rest with 1 of the following ECG features:
• ST segment elevation ≥2 contiguous ECG leads
• new or presumably new left bundle branch block
• In patients with multivessel disease, treatment only of the culprit lesion / target vessel during primary PCI is recommended.
• Eligibility at 30-45 days
• All patients who have provided informed consent
• Compliance to DAPT with no regimen modifications (Non-adherence Academic Research Consortium 0)
• No occurrence of significant event (such as MI, unplanned revascularisation, stent thrombosis, stroke, major vascular complication/bleeding BARC Types 3 or greater).
• Successful revascularization: - Successful delivery and deployment of the Study device(s), with final residual stenosis of <30% (visually) for all target lesions.
• Complete revascularization performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 15 days from the index procedure. Physiologic assessment highly recommended for lesions with stenosis between 50% and 90%.

You may not qualify if…

• Patients on oral anticoagulation
• Contraindication to P2Y12 inhibitors and/or to Cardioaspirin or to any of the excipients (hypersensitivity, history of any stroke or transient ischemic attack within the last 12 months, active bleeding or haemorrhagic diathesis, fibrin-specific fibrinolytic therapy less than 24 h before randomization, severe hepatic dysfunction (Child-Pugh C), history of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines, history of gastrointestinal perforation or acute gastrointestinal ulcers, severe cardiac failure (NYHA grade III or IV), combination with methotrexate at doses of 15 mg/week or more).
• Patients who have received P2Y12 inhibitors other than Prasugrel in the ambulance (Ticagrelor or Clopidogrel loading dose) or are already on P2Y12 inhibitors, may be enrolled in the protocol, provided that the Prasugrel loading dose is administered at admission, according to current guidelines recommendations (see section 5.2.2).
• Concomitant oral or i.v. therapy with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice >1L/day), CYP3A substrates with narrow therapeutic indices (e.g., cyclosporine, quinidine), or strong CYP3A inducers (e.g., rifampin), - rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital
• Platelet count <100.000/μL at the time of screening
• Anemia (hemoglobin <10 g/dL) at the time of screening
• Comorbidities associated with life expectancy <1 year
• Pregnancy, giving birth within the last 90 days, or lactation (see appendix III for women of childbearing potential)
• PCI indication for stent thrombosis or previous history of definite stent thrombosis
• Non-deferrable major surgery on DAPT after PCI
• Cardiogenic shock
• Out of hospital cardiac arrest (OHCA) unless survivors of ventricular arrythmia with prompt return of spontaneous circulation (ROSC)
• Patients with severe renal impairment: creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR).
• Patients participating in another interventional (device of drug trial) within the previous 12 months or patients to whom an investigational drug was administered in the 30 days prior to screening, or 5 half-lives of the study drug, whichever is longer.
• No informed consent

Where it is running

• Institute for CVD Vojvodine — Kamenitz, Serbia (enrolling)
• Imelda Bonheiden — Bonheiden, Belgium (enrolling)
• AZ St.Jan — Bruges, Belgium (enrolling)
• ZOL Genk — Genk, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• AZ Delta — Roeselare, Belgium (enrolling)
• FN BRNO — Brno, Czechia (enrolling)
• Masaryk Hospital Usti nad Labem - — Hradec Králové, Czechia (enrolling)
• University Gemelli — Roma, Italy (enrolling)
• Asklepios Klinik Bad Oldesloe — Bad Oldesloe, Germany (enrolling)
• Segeberger Kliniken — Bad Segeberg, Germany (enrolling)
• University hospital Dresden — Dresden, Germany (enrolling)
• Ospedale Papa Giovanni XXIII — Bergamo, Italy (enrolling)
• University of Ferrara — Ferrara, Italy (enrolling)
• University San Martino — Genova, Italy (enrolling)
• Centro Cardiologico Monzino IRCCS — Milan, Italy (enrolling)
• University Federico II — Naples, Italy (enrolling)
• Amphia Ziekenhuis — Breda, Netherlands (enrolling)
• Albert Schweitzer ziekenhuis — Dordrecht, Netherlands (enrolling)
• Catherina ziekenhuis — Eindhoven, Netherlands (enrolling)
• RadboudUMC — Nijmegen, Netherlands (enrolling)
• Erasmus Medical Center — Rotterdam, Netherlands (enrolling)
• Maasstadziekenhuis — Rotterdam, Netherlands (enrolling)
• Haga hospital — The Hague, Netherlands (enrolling)
• Institute for CVD Dedinje — Belgrade, Serbia (enrolling)

Full record on ClinicalTrials.gov

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