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ClinicalTrials.gov Identifier: NCT00250471
Recruitment Status : Completed
First Posted : November 8, 2005
Last Update Posted : November 8, 2005
Information provided by:
Millennium Pharmaceuticals, Inc.

Brief Summary:
The primary purpose of this study was to compare the efficacy and safety of bivalirudin to eptifibatide (with or without unfractionated heparin or enoxaparin)given to subjects at high risk for heart attack and other cardiovascular complications who will undergo surgery to open up blocked arteries in the heart.

Condition or disease Intervention/treatment Phase
Unstable Angina Procedure: Percutaneous Coronary Intervention (PCI) Phase 3

Detailed Description:
Platelet inhibitor drugs

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Study Type : Interventional  (Clinical Trial)
Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial to Evaluate the Relative Protection Against Post-PCI Microvascular Dysfunction and Post-PCI Ischemia Among Anti-Platelet and Anti-Thrombotic Agents
Study Start Date : May 2003
Study Completion Date : September 2004

Primary Outcome Measures :
  1. Efficacy: Improved Coronary Flow Reserve
  2. Safety: TIMI major hemorrhage within 48 hours after randomizing in the trial or hosptial discharge, which ever occurs first.

Secondary Outcome Measures :
  1. Duration of ischemia on continuous EKG monigoring through 24 hours after surgery.
  2. Composite death, heart attack and any occurance of ischemia based on the Holter monitor recording within 48 hours after randomizing into the trial

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Chest paing/discomfort that occurs at rest and lasts at least 10 minutes and have at least one of the following high-risk features:

    • diabetes
    • elevated cardiac proteins in the blood (indicating acute coronary syndrome)
  • Be willing and able to give informed consent

Exclusion Criteria:

  • uncontrolled hypertension
  • cardiac episode (heart attack) within the previous 24 hours before randomization into the trial
  • prior heart surgery (PCI) within the previous 2 weeks before randomizing in the trial
  • any electorcardogram (ECG) finding that make the Holter monitor for ischemia unable to read
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00250471    
Other Study ID Numbers: 03-046
First Posted: November 8, 2005    Key Record Dates
Last Update Posted: November 8, 2005
Last Verified: November 2005
Keywords provided by Millennium Pharmaceuticals, Inc.:
GP IIb/IIIa inhibitors
Anti-thrombotic agents
Additional relevant MeSH terms:
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Angina, Unstable
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations