PROTECT-TIMI 30 Trial

Unstable Angina Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250471
• Other study ID #: 03-046
• Status: Completed
• Phase: Phase 3
• First received: November 7, 2005
• Last updated: November 7, 2005
• Start date: May 2003
• Est. completion date: September 2004

Study information

• Verified date: November 2005
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Platelet inhibitor drugs

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Unstable
• Unstable Angina

Intervention

Procedure:
• Percutaneous Coronary Intervention (PCI)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Improved Coronary Flow Reserve
Primary	Safety: TIMI major hemorrhage within 48 hours after randomizing in the trial or hosptial discharge, which ever occurs first.
Secondary	Duration of ischemia on continuous EKG monigoring through 24 hours after surgery.
Secondary	Composite death, heart attack and any occurance of ischemia based on the Holter monitor recording within 48 hours after randomizing into the trial