Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

Phase 4

Completed

• Conditions: Actue Coronary Syndromes

• Registration Number: NCT00382460
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-11
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Study First Submitted: 2006-09-27
• Study First Submitted QC: 2006-09-27
• Study First Posted: 2006-09-29
• Disposition First Submitted: 2010-02-15
• Disposition First Submitted QC: 2010-02-15
• Disposition First Posted: 2010-02-17
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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