Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Actue Coronary Syndromes

Treatments: Drug: PRAVASTATIN SODIUM

Study type: Interventional

Funder types: Industry

Identifiers

NCT00382460

CV123-229

TIMI22

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind