Clinical Trial: PROTECT-TIMI 30 Trial
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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 Summary: Platelet inhibitor drugs
Sponsor: Millennium Pharmaceuticals, Inc.
Current Primary Outcome:
- Efficacy: Improved Coronary Flow Reserve
- Safety: TIMI major hemorrhage within 48 hours after randomizing in the trial or hosptial discharge, which ever occurs first.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: Millennium Pharmaceuticals, Inc.
Dates:
Date Received: November 7, 2005
Date Started: May 2003
Date Completion: September 2004
Last Updated: November 7, 2005
Last Verified: November 2005
