drugset / Trial / NCT00289601

Randomized Study of Aspirin Resistant Patients Undergoing Angioplasty

NCT00289601 ↗

Phase 4 Terminated 1200 enrolled Brigham and Women's Hospital Schering-Plough · collab
RandomizedSingle-groupDouble-blindTreatment

Summary

This study is a randomized, double-blind, multi-center study designed to compare differences in rates of myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times ULN) within 24 hours following low-medium risk percutaneous coronary intervention (PCI) in aspirin or clopidogrel non-responsive patients who are randomized to heparin with or without eptifibatide therapy during PCI. The primary objective of this study is to determine if the use of eptifibatide is associated with a significant difference in post-PCI myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times upper limit of normal \[ULN\]) within 24 hours of low-medium risk PCI in patients who are aspirin or non-responsive as determined by VerifyNow Aspirin and P2Y12 testing.

Timeline

Start
2006-03
Primary completion
—
Completion
2007-12

Outcome

Outcome not reported

Stopped: “Sponsor support withdrawn”

Drugs

EvaluationDrugModalityDoseRoute
Subject Eptifibatide Other / unclassified — —

Indications

No indication recorded.