Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atorvastatin Calcium; Pravastatin

Criteria

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