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PROTECT-TIMI 30 Trial

Sponsor
Millennium Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00250471
Collaborator
(none)
900
Enrollment
16.1
Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Percutaneous Coronary Intervention (PCI)
 Phase 3

Detailed Description

Platelet inhibitor drugs

Study Design

Study Type:
Interventional
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
Study Start Date :
May 1, 2003
Study Completion Date :
Sep 1, 2004

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Millennium Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00250471
Other Study ID Numbers:
  • 03-046
First Posted:
Nov 8, 2005
Last Update Posted:
Nov 8, 2005
Last Verified:
Nov 1, 2005
Keywords provided by , ,
GP IIb/IIIa inhibitors
eptifibatide
Anti-thrombotic agents
Additional relevant MeSH terms:
Angina, Unstable

Study Results

No Results Posted as of Nov 8, 2005