Sponsor Name

Research Maatschap Cardiologen Rotterdam Zuid

Brief summary

This is an investigator initiated multi-center, open-label, randomized (1:1) controlled trial comparing Prasugrel-based short (30-45 days) Dual-Antiplatelet-Therapy (DAPT) followed by Prasugrel monotherapy versus standard 12-month DAPT regimen in 1656 STEMI patients.

Study objectives

The primary objective of this study is to prove noninferiority regarding safety and effectiveness of short DAPT followed by Prasugrel monotherapy versus standard 12 months of DAPT in patients admitted for STEMI treated by primary PCI. The ancillary objective of the study is to prove that OCT-guided revascularization completion by staged PCI is superior to an angio-guided approach in patients with multivessel disease who have received guideline-based treatment of the culprit lesion.

Primary endpoints

Incidence of Net Adverse Clinical Events (NACE) at 11 months post DAPT randomization as composite of death, MI, stroke or BARC bleeding 3 or 5.

Co- primary endpoint: Post-procedural Minimal Stent Area (MSA)

CERC Services

CEC

Safety reporting

Imaging Corelab analyses

Statistics

Countries

The Netherlands, Germany and Italy 

Number of investigational sites: 15