Comparing short-term and standard antiplatelet therapy in heart attack 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

This study tests whether a shorter course of a specific heart medication can help heart attack patients recover as well as the standard longer treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1656 (estimated)
• Sex: All
• Sponsor: Research Maatschap Cardiologen Rotterdam Zuid (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 26 sites (Bonheiden and 25 other locations)
• Trial ID: NCT05491200 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multi-center, open-label, randomized controlled trial that compares a short duration of dual antiplatelet therapy (DAPT) followed by prasugrel monotherapy against a standard DAPT regimen in patients with ST-Elevated Myocardial Infarction (STEMI). Patients will be treated with prasugrel and ASA during their primary percutaneous coronary intervention (PCI), and those with multivessel disease will undergo staged procedures for complete revascularization. The study will also evaluate the efficacy and safety of OCT-guided versus angiography-guided revascularization strategies. Follow-up will occur over 35 months to assess clinical outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with ST-Elevated Myocardial Infarction who are planned for primary PCI.

Not a fit: Patients with significant complications or those who do not adhere to the DAPT regimen may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and safer antiplatelet therapy strategies for heart attack patients.

How similar studies have performed: Other studies have shown promising results with similar approaches to antiplatelet therapy, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

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%.

Exclusion criteria

* 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 this trial is running

Bonheiden and 25 other locations

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

Study contacts

• Principal investigator: Valeria Paradies, MD, PhD — Research Maatschap Cardiologen Rotterdam Zuid
• Study coordinator: Valeria Paradies, MD

Conditions ST Elevated Myocardial Infarction; Dual Antiplatelet Therapy