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

• Status: Recruiting
• Trial end date: 2028-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Research Maatschap Cardiologen Rotterdam Zuid
• Collaborator: Abbott Medical Devices
• Treatments: Prasugrel Hydrochloride

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, within 24 h prior to randomization 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 (hypersensitivity, history of any stroke or transient ischemic attack within the last 12 months, active bleeding, fibrin-specific fibrinolytic therapy less than 24 h before randomization, chronic renal insufficiency requiring dialysis, moderate or severe hepatic dysfunction)

• 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, dexamethasone, 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

• 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)

• No informed consent