PROTECT-TIMI 30 Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2004-09-30

Brief Summary

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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

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Platelet inhibitor drugs

Conditions

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Unstable Angina

Keywords

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GP IIb/IIIa inhibitors eptifibatide Anti-thrombotic agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Percutaneous Coronary Intervention (PCI)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

References

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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.

Reference Type DERIVED

PMID: 19699861 (View on PubMed)

Other Identifiers

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03-046

Identifier Type: -

Identifier Source: org_study_id