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

Sponsor
Chonnam National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02446730
Collaborator
(none)
1,400
Enrollment
1
Location
2
Arms
35
Duration (Months)
40
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
Aug 1, 2017
Anticipated Study Completion Date :
Aug 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: BES with Prasugel 5mg

Biolimus-eluting stent with Prasugrel 5mg once daily MD

Device: BES (biodegradable polymer biolimus-eluting stent)
BES implantation
Other Names:
  • BiomatirxTM
  • Biomatrix FlexTM

    • Drug: Prasugel
    Active Comparator: BES with Clopidogrel 75mg

    Biolimus-eluting stent with Clopidogrel 75mg once daily MD

    Device: BES (biodegradable polymer biolimus-eluting stent)
    BES implantation
    Other Names:
  • BiomatirxTM
  • Biomatrix FlexTM

    • Drug: Clopidogrel

    Outcome Measures

    Primary Outcome Measures

    1. A compoiste of cardiac death, non-fatal myocardiac infarction and stroke [within the 1 year after BIOMATRIXTM Stent implantation]

    Secondary Outcome Measures

    1. All-cause death [within the 1 year after BIOMATRIXTM Stent implantation]

    2. Cardiac death [within the 1 year after BIOMATRIXTM Stent implantation]

    3. non-fatal myocardial infarction [within the 1 year after BIOMATRIXTM Stent implantation]

    4. Stroke [within the 1 year after BIOMATRIXTM Stent implantation]

    5. Target lesion revascularization [within the 1 year after BIOMATRIXTM Stent implantation]

    6. stent thrombosis [within the 1 year after BIOMATRIXTM Stent implantation]

    7. BARC bleeding 2,3,and 5 [within the 1 year after BIOMATRIXTM Stent implantation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jung-Me Lee Pusan Korea, Republic of

    Sponsors and Collaborators

    • Chonnam National University Hospital

    Investigators

    • Principal Investigator: Myung Ho Jeong, PhD, Chonnam National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Myung Ho Jeong, MD, PhD, Chonnam National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02446730
    Other Study ID Numbers:
    • BEAUTY-II
    First Posted:
    May 18, 2015
    Last Update Posted:
    May 18, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Stroke
    Myocardial Infarction
    Acute Coronary Syndrome
    Infarction
    Hemorrhage
    Death
    Clopidogrel

    Study Results

    No Results Posted as of May 18, 2015