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PROTECT-TIMI 30 Trial

Primary Purpose

Unstable Angina

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention (PCI)
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unstable Angina focused on measuring GP IIb/IIIa inhibitors, eptifibatide, Anti-thrombotic agents

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    November 7, 2005
    Last Updated
    November 7, 2005
    Sponsor
    Millennium Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00250471
    Brief Title
    PROTECT-TIMI 30 Trial
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Millennium Pharmaceuticals, Inc.

    4. Oversight

    5. 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.
    Detailed Description
    Platelet inhibitor drugs

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Unstable Angina
    Keywords
    GP IIb/IIIa inhibitors, eptifibatide, Anti-thrombotic agents

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    900 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Percutaneous Coronary Intervention (PCI)
    Primary Outcome Measure Information:
    Title
    Efficacy: Improved Coronary Flow Reserve
    Title
    Safety: TIMI major hemorrhage within 48 hours after randomizing in the trial or hosptial discharge, which ever occurs first.
    Secondary Outcome Measure Information:
    Title
    Duration of ischemia on continuous EKG monigoring through 24 hours after surgery.
    Title
    Composite death, heart attack and any occurance of ischemia based on the Holter monitor recording within 48 hours after randomizing into the trial

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19699861
    Citation
    Wilson SR, Sabatine MS, Braunwald E, Sloan S, Murphy SA, Morrow DA. Detection of myocardial injury in patients with unstable angina using a novel nanoparticle cardiac troponin I assay: observations from the PROTECT-TIMI 30 Trial. Am Heart J. 2009 Sep;158(3):386-91. doi: 10.1016/j.ahj.2009.06.011. Epub 2009 Jul 15.
    Results Reference
    derived

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    PROTECT-TIMI 30 Trial

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