Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome
NCT ID: NCT02446730
Last Updated: 2015-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1400 participants
INTERVENTIONAL
2014-09-30
2017-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BES with Prasugel 5mg
Biolimus-eluting stent with Prasugrel 5mg once daily MD
BES (biodegradable polymer biolimus-eluting stent)
BES implantation
Prasugel
BES with Clopidogrel 75mg
Biolimus-eluting stent with Clopidogrel 75mg once daily MD
BES (biodegradable polymer biolimus-eluting stent)
BES implantation
Clopidogrel
Interventions
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BES (biodegradable polymer biolimus-eluting stent)
BES implantation
Prasugel
Clopidogrel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 75 years old or younger,
* body weight of 60 kg or more and diagnosed with acute coronary syndrome
Exclusion Criteria
* 75 years old or older,
* body weight of 60 kg or under,
* hypersensitivity to or contraindicated for heparin, aspirin, clopidogrel, prasugrel or contrast media
18 Years
75 Years
ALL
Yes
Sponsors
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Chonnam National University Hospital
OTHER
Responsible Party
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Myung Ho Jeong
MD, PhD
Principal Investigators
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Myung Ho Jeong, PhD
Role: PRINCIPAL_INVESTIGATOR
Chonnam National University Hospital
Locations
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Jung-Me Lee
Pusan, , South Korea
Countries
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Central Contacts
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Myung-Ho Jeong, PhD
Role: CONTACT
Facility Contacts
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Myung-Ho, Jeong
Role: primary
Other Identifiers
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BEAUTY-II
Identifier Type: -
Identifier Source: org_study_id
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