Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)
This study has been completed.
First Posted: September 29, 2006
Last Update Posted: April 15, 2011
Information provided by:
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 Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Prevention
|Official Title:||Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)|
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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:
- To compare the risk of nonfatal MI or coronary heart disease death between pravastatin and atorvastatin, and gatifloxacin and placebo.
|Study Start Date:||November 2000|
|Study Completion Date:||December 2003|
|Primary Completion Date:||December 2003 (Final data collection date for primary outcome measure)|
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