NCT02446730

Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome

A Prospective, Multicenter, Randomized, Open-label Trial to Evaluate Efficacy and Safety of 5mg Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome Who Underwent Percutaneous Coronary Intervention With BiomatrixTM Stent

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,400 (estimated)
• Sponsor: Chonnam National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of 5mg maintenance dose (MD) of prasugrel in patients with acute myocardial infarction (AMI) who underwent percutaneous coronary intervention (PCI) with BiomatrixTM stent.

Detailed description

About 1400 patients derived from Korean patients with acute coronary syndrome (ACS) receiving percutaneous coronary intervention (PCI) with BES(Biolimus-eluting stent, BiomatrixTM) in a routine manner will be enrolled in the investigators trial. These patients will be randomized 1:1 to either prasugrel 5mg once daily MD or clopidogrel 75mg once daily MD after successful PCI with BES . The investigators excluded the patients with age ≥75 years, body weight \<60 kg, or history of TIA (transient ischemic attack) or stroke. Follow-up data will be collected until 1-year after index procedure. Primary efficacy end-point defined as the composite of cardiac death, non-fatal MI, stent thrombosis and ischemic driven target vessel revascularization and safety end-points as BARC (the Bleeding Academic Research Consortium) type ≥ 2 bleeding.

Conditions

• Cardiac Death
• Hemorrhage
• Cerebrovascular Accident
• Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	BES (biodegradable polymer biolimus-eluting stent)	BES implantation
DRUG	Prasugel
DRUG	Clopidogrel

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2015-05-18
• Last updated: 2015-05-18

Locations

1 site across 1 country: South Korea