PROTECT-TIMI 30 Trial
A Randomized Trial to Evaluate the Relative Protection Against Post-PCI Microvascular Dysfunction and Post-PCI Ischemia Among Anti-Platelet and Anti-Thrombotic Agents
1 other identifier
interventional
900
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2003
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 7, 2005
CompletedFirst Posted
Study publicly available on registry
November 8, 2005
CompletedNovember 8, 2005
November 1, 2005
November 7, 2005
November 7, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 19699861DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 7, 2005
First Posted
November 8, 2005
Study Start
May 1, 2003
Study Completion
September 1, 2004
Last Updated
November 8, 2005
Record last verified: 2005-11