Current partner codePEPTIDESDE
NCT00250471·Phase 3·INTERVENTIONAL

PROTECT-TIMI 30 Trial

Status

Completed

Phase

Phase 3

Enrollment

900

Locations

0

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Full detailed description

Platelet inhibitor drugs

Interventions

Treatment arms and agents.

PROCEDURE

Percutaneous Coronary Intervention (PCI)

Timeline

From registration to results.

  1. First posted

    Nov 8, 2005

  2. Study start

    May 2003

  3. Primary completion

    Not reported

  4. Study completion

    Sep 2004

  5. Results posted

    Not reported

  6. Registry updated

    Nov 8, 2005

Outcomes

What the study measures.

Primary outcomes

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
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

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Related trials

More studies on Eptifibatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.