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Pravastatin or Atorvastatin E...

Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

Last Updated: 2011-04-15

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

PHASE4

Total Enrollment

4000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Study Completion Date

2003-12-31

Brief Summary

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The primary purpose of the study was to evaluate 4000 subjects with acute coronary syndrome by comparing pravastatin 40 mg to atorvastatin 80 mg to determine if they are clinically equivalent, and to evaluate the effectiveness of gatifloxacin therapy in reducing cardiovascular events in combination with statin therapy.

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Detailed Description

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Conditions

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Actue Coronary Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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PRAVASTATIN SODIUM

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hospitalization for MI or high risk unstable angina within the last 10 days.
* Total cholesterol 240 mg/dl or greater.
* Stabilized post ACS

Exclusion Criteria

* Co-morbidity with life expectations no more than 2 years.
* Current lipid lowering therapy
* Corrected QT interval
* Need for Class IA or III antiarrhythmic agent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers