PROCEDURE
Status
Completed
Phase
Phase 3
Enrollment
900
Locations
0
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Full detailed description
Platelet inhibitor drugs
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Nov 8, 2005
Study start
May 2003
Primary completion
Not reported
Study completion
Sep 2004
Results posted
Not reported
Registry updated
Nov 8, 2005
Outcomes
What the study measures.
Primary outcomes
Efficacy: Improved Coronary Flow Reserve
Safety: TIMI major hemorrhage within 48 hours after randomizing in the trial or hosptial discharge, which ever occurs first.
Secondary outcomes
Duration of ischemia on continuous EKG monigoring through 24 hours after surgery.
Composite death, heart attack and any occurance of ischemia based on the Holter monitor recording within 48 hours after randomizing into the trial
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- ALL
- 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
Study locations
0 registered sites.
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
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Related PeptideStat pages
Put the record in context.
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