PROTECT-TIMI 30 Trial
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.
Procedure: Percutaneous Coronary Intervention (PCI)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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|
- Efficacy: Improved Coronary Flow Reserve
- Safety: TIMI major hemorrhage within 48 hours after randomizing in the trial or hosptial discharge, which ever occurs first.
- 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
|Study Start Date:||May 2003|
|Estimated Study Completion Date:||September 2004|
Platelet inhibitor drugs