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

Recruiting

Phase 4 Results N/A

Trial Description

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

Interventions

  • Clopidogrel (Plavix®)Drug
    Other Names: Plavix
    ARM 1: Kind: Experimental
    Label: BES with Clopidogrel 75mg
    Description: Biolimus-eluting stent with Clopidogrel 75mg once daily MD
  • BES (biodegradable polymer biolimus-eluting stent) Device
    Other Names: BiomatirxTM; Biomatrix FlexTM
    Intervention Desc: BES implantation
    ARM 1: Kind: Experimental
    Label: BES with Prasugel 5mg
    Description: Biolimus-eluting stent with Prasugrel 5mg once daily MD
    ARM 2: Kind: Experimental
    Label: BES with Clopidogrel 75mg
    Description: Biolimus-eluting stent with Clopidogrel 75mg once daily MD
  • Prasugel Drug
    ARM 1: Kind: Experimental
    Label: BES with Prasugel 5mg
    Description: Biolimus-eluting stent with Prasugrel 5mg once daily MD

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary A compoiste of cardiac death, non-fatal myocardiac infarction and stroke within the 1 year after BIOMATRIXTM Stent implantation No
Secondary All-cause death within the 1 year after BIOMATRIXTM Stent implantation No
Secondary Cardiac death within the 1 year after BIOMATRIXTM Stent implantation No
Secondary non-fatal myocardial infarction within the 1 year after BIOMATRIXTM Stent implantation No
Secondary Stroke within the 1 year after BIOMATRIXTM Stent implantation No
Secondary Target lesion revascularization within the 1 year after BIOMATRIXTM Stent implantation No
Secondary stent thrombosis within the 1 year after BIOMATRIXTM Stent implantation No
Secondary BARC bleeding 2,3,and 5 within the 1 year after BIOMATRIXTM Stent implantation Yes

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