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Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 29, 2006
Last Update Posted: April 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
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 Intervention Phase
Actue Coronary Syndromes Drug: PRAVASTATIN SODIUM Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
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.

Estimated Enrollment: 4000
Study Start Date: November 2000
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)

Information from the National Library of Medicine

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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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

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 Submitted: September 27, 2006
First Posted: September 29, 2006
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