PROTECT-TIMI 30 Trial

Millennium Pharmaceuticals, Inc.900 enrolled

Overview

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.

Platelet inhibitor drugs

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

900

Conditions

Unstable Angina

Interventions

Percutaneous Coronary Intervention (PCI)PROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

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

Data from ClinicalTrials.gov

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