A Randomized Trial to Evaluate the Relative Protection Against Post-PCI Microvascular Dysfunction and Post-PCI Ischemia Among Anti-Platelet and Anti-Thrombotic Agents

Millennium Pharmaceuticals, Inc.0 个研究点目标入组 900 人开始时间: 2003年5月最近更新: 2005年11月8日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Millennium Pharmaceuticals, Inc.
入组人数: 900
主要终点: Efficacy: Improved Coronary Flow Reserve

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

详细描述

Platelet inhibitor drugs

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Chest paing/discomfort that occurs at rest and lasts at least 10 minutes and have at least one of the following high-risk features:
•elevated cardiac proteins in the blood (indicating acute coronary syndrome)
•Be willing and able to give informed consent

排除标准

•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

结局指标

主要结局

Efficacy: Improved Coronary Flow Reserve

Safety: TIMI major hemorrhage within 48 hours after randomizing in the trial or hosptial discharge, which ever occurs first.

次要结局

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

研究者

发起方

Millennium Pharmaceuticals, Inc.

申办方类型

Industry

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