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PROTECT-TIMI 30 Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00250471
First Posted: November 8, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Millennium Pharmaceuticals, Inc.
  Purpose
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.

Condition Intervention Phase
Unstable Angina Procedure: Percutaneous Coronary Intervention (PCI) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Efficacy: Improved Coronary Flow Reserve
  • Safety: TIMI major hemorrhage within 48 hours after randomizing in the trial or hosptial discharge, which ever occurs first.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 900
Study Start Date: May 2003
Estimated Study Completion Date: September 2004
Detailed Description:
Platelet inhibitor drugs
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00250471     History of Changes
Other Study ID Numbers: 03-046
First Submitted: November 7, 2005
First Posted: November 8, 2005
Last Update Posted: December 9, 2005
Last Verified: November 2005

Keywords provided by Millennium Pharmaceuticals, Inc.:
GP IIb/IIIa inhibitors
eptifibatide
Anti-thrombotic agents

Additional relevant MeSH terms:
Angina, Unstable
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action