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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Cardiac Death, Hemorrhage, Cerebrovascular Accident, Myocardial Infarction

Intervention / Treatment
-----------------
* Device: BES (biodegradable polymer biolimus-eluting stent)
* Drug: Prasugel
* Drug: Clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BES with Prasugel 5mg<br>Biolimus-eluting stent with Prasugrel 5mg once daily MD | Device: BES (biodegradable polymer biolimus-eluting stent)<br>* BES implantation<br>* Other names: Biomatrix FlexTM;Drug: Prasugel<br> <br> |
| Active Comparator: BES with Clopidogrel 75mg<br>Biolimus-eluting stent with Clopidogrel 75mg once daily MD | Device: BES (biodegradable polymer biolimus-eluting stent)<br>* BES implantation<br>* Other names: Biomatrix FlexTM;Drug: Clopidogrel<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A compoiste of cardiac death, non-fatal myocardiac infarction and stroke |  | within the 1 year after BIOMATRIXTM Stent implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death |  | 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 | 
| Target lesion revascularization |  | within the 1 year after BIOMATRIXTM Stent implantation | 
| stent thrombosis |  | within the 1 year after BIOMATRIXTM Stent implantation | 
| BARC bleeding 2,3,and 5 |  | within the 1 year after BIOMATRIXTM Stent implantation |