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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
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Actue Coronary Syndromes Drug: PRAVASTATIN SODIUM Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. To demonstrate the clinical equivalence of pravastatin 40 mg and atorvastatin 80 mg in reducing death or major cardiovascular event after 2 years
  2. 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 :
  1. To compare the risk of nonfatal MI or coronary heart disease death between pravastatin and atorvastatin, and gatifloxacin and placebo.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00382460     History of Changes
Other Study ID Numbers: CV123-229
First Posted: September 29, 2006    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors