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.
Sponsor
Research Maatschap Cardiologen Rotterdam Zuid
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
- Clinical Events Committee (CEC) activities
- Safety management
- CoreLab activities
- Statistical Activities
Countries
The Netherlands, Germany, Italy
Number of investigational sites
15
Number of patients
1656
