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

Phase 4

• Conditions: Myocardial Infarction; Cardiac Death; Cerebrovascular Accident; Hemorrhage
• Interventions: Device: BES (biodegradable polymer biolimus-eluting stent); Drug: Prasugel; Drug: Clopidogrel

• Registration Number: NCT02446730
• Lead Sponsor: Chonnam National University Hospital

Brief 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.

Study Timeline

• Study Start: 2014-09
• Status Verified: 2015-05
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-15
• Last Update Submitted: 2015-05-15
• Study First Posted: 2015-05-18
• Last Update Posted: 2015-05-18
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

• Patients who can undergo percutaneous coronary intervention with Biomatrix stent with no history of TIA or stroke,
• 75 years old or younger,
• body weight of 60 kg or more and diagnosed with acute coronary syndrome

Exclusion Criteria

• Patients with history of TIA or stroke,
• 75 years old or older,
• body weight of 60 kg or under,
• hypersensitivity to or contraindicated for heparin, aspirin, clopidogrel, prasugrel or contrast media

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BES with Prasugel 5mg	Prasugel	Biolimus-eluting stent with Prasugrel 5mg once daily MD
BES with Clopidogrel 75mg	Clopidogrel	Biolimus-eluting stent with Clopidogrel 75mg once daily MD
BES with Prasugel 5mg	BES (biodegradable polymer biolimus-eluting stent)	Biolimus-eluting stent with Prasugrel 5mg once daily MD
BES with Clopidogrel 75mg	BES (biodegradable polymer biolimus-eluting stent)	Biolimus-eluting stent with Clopidogrel 75mg once daily MD

Primary Outcome Measures

Name	Time	Method
A compoiste of cardiac death, non-fatal myocardiac infarction and stroke	within the 1 year after BIOMATRIXTM Stent implantation

Secondary Outcome Measures

Name	Time	Method
stent thrombosis	within the 1 year after BIOMATRIXTM Stent implantation
All-cause death	within the 1 year after BIOMATRIXTM Stent implantation
Target lesion revascularization	within the 1 year after BIOMATRIXTM Stent implantation
BARC bleeding 2,3,and 5	within the 1 year after BIOMATRIXTM Stent implantation
Cardiac death	within the 1 year after BIOMATRIXTM Stent implantation
non-fatal myocardial infarction	within the 1 year after BIOMATRIXTM Stent implantation
Stroke	within the 1 year after BIOMATRIXTM Stent implantation

Trial Locations

Locations (1)

Jung-Me Lee; 🇰🇷 Pusan, Korea, Republic of