Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)
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|ClinicalTrials.gov Identifier: NCT00382460|
Recruitment Status : Completed
First Posted : September 29, 2006
Last Update Posted : April 15, 2011
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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.
|Condition or disease||Intervention/treatment||Phase|
|Actue Coronary Syndromes||Drug: PRAVASTATIN SODIUM||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4000 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)|
|Study Start Date :||November 2000|
|Primary Completion Date :||December 2003|
|Study Completion Date :||December 2003|
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.
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