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OpenTrials
Completed

NCT Number: NCT00250471

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.

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Key information

Conditions

Unstable Angina Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

Platelet inhibitor drugs

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Coronary Intervention (PCI)

Procedure

Primary outcomes

  1. Efficacy: Improved Coronary Flow Reserve

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

Secondary outcomes

  1. Duration of ischemia on continuous EKG monigoring through 24 hours after surgery.

  2. Composite death, heart attack and any occurance of ischemia based on the Holter monitor recording within 48 hours after randomizing into the trial

Sponsors and collaborators

Lead sponsor

Millennium Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Nov 8, 2005
Registry last updated
Nov 8, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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