NCT05491200

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,656 (estimated)
• Sponsor: Research Maatschap Cardiologen Rotterdam Zuid · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Consecutive patients with STEMI planned for pPCI will be screened for eligibility criteria and treated as per standard of care with ASA and Prasugrel 60 mg loading dose. The culprit lesion will be treated during the index procedure. Non culprit lesions in patients with MVD will be treated during staged procedure(s), in any case last instalment of staged procedure(s) should be scheduled within 15 days after index procedure. Complete revascularization of non culprit lesions will be allocated to either OCT- or angio-guided strategy (OCT randomization). At 30-45 days follow-up after index procedure, if inclusion criteria are met, patients will be randomized to prasugrel monotherapy or standard DAPT regimen (DAPT randomization). The follow-up duration is 35 months after DAPT randomization, i.e. clinical outcomes will be analysed at 11 and 35 months after DAPT randomization.

Conditions

• ST Elevated Myocardial Infarction
• Dual Antiplatelet Therapy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-22
• Primary completion: 2026-08-01
• Completion: 2028-08-01
• First posted: 2022-08-08
• Last updated: 2025-08-06

Locations

26 sites across 6 countries: Belgium, Czechia, Germany, Italy, Netherlands, Serbia