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

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ClinicalTrials.gov Identifier: NCT02446730
Recruitment Status : Unknown
Verified May 2015 by Myung Ho Jeong, Chonnam National University Hospital.
Recruitment status was:  Recruiting
First Posted : May 18, 2015
Last Update Posted : May 18, 2015
Sponsor:
Information provided by (Responsible Party):
Myung Ho Jeong, 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.

Condition or disease Intervention/treatment Phase
Cardiac Death Hemorrhage Cerebrovascular Accident Myocardial Infarction Device: BES (biodegradable polymer biolimus-eluting stent) Drug: Prasugel Drug: Clopidogrel 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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2014
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


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



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

Secondary Outcome Measures :
  1. All-cause death [ Time Frame: within the 1 year after BIOMATRIXTM Stent implantation ]
  2. Cardiac death [ Time Frame: within the 1 year after BIOMATRIXTM Stent implantation ]
  3. non-fatal myocardial infarction [ Time Frame: within the 1 year after BIOMATRIXTM Stent implantation ]
  4. Stroke [ Time Frame: within the 1 year after BIOMATRIXTM Stent implantation ]
  5. Target lesion revascularization [ Time Frame: within the 1 year after BIOMATRIXTM Stent implantation ]
  6. stent thrombosis [ Time Frame: within the 1 year after BIOMATRIXTM Stent implantation ]
  7. BARC bleeding 2,3,and 5 [ Time Frame: within the 1 year after BIOMATRIXTM Stent implantation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446730


Contacts
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Contact: Myung-Ho Jeong, PhD +82-062-220-5114

Locations
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Korea, Republic of
Jung-Me Lee Recruiting
Pusan, Korea, Republic of
Contact: Myung-Ho , Jeong    +82-62-220-5114      
Sponsors and Collaborators
Chonnam National University Hospital
Investigators
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Principal Investigator: Myung Ho Jeong, PhD Chonnam National University Hospital

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Responsible Party: Myung Ho Jeong, MD, PhD, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT02446730     History of Changes
Other Study ID Numbers: BEAUTY-II
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: May 18, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Stroke
Myocardial Infarction
Acute Coronary Syndrome
Infarction
Hemorrhage
Death
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Clopidogrel
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs