PROTECT-TIMI 30 Trial
Phase 3
Completed
- Conditions
- Unstable Angina
- Registration Number
- NCT00250471
- Lead Sponsor
- 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.
- Detailed Description
Platelet inhibitor drugs
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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