Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

Bristol-Myers Squibb4,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

4,000

Conditions

Actue Coronary Syndromes

Interventions

PRAVASTATIN SODIUMDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

To demonstrate the clinical equivalence of pravastatin 40 mg and atorvastatin 80 mg in reducing death or major cardiovascular event after 2 years

To demonstrate in subjects with ACS that Gatifloxacin is effective in reducing death or major cardiovascular event after 2 years, compared to placebo.

Secondary Outcomes

To compare the risk of nonfatal MI or coronary heart disease death between pravastatin and atorvastatin, and gatifloxacin and placebo.

Data from ClinicalTrials.gov

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