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...
Date First Received: September 27, 2006
Last Updated: June 27, 2008
Verified by: Bristol-Myers Squibb, September 2007
Clinical Trial Phase: Phase 4 | Start Date: January 2001
Overall Status: Completed
Estimated Enrollment: 4000
Brief Summary
Official Title: “Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Dose Comparison, Factorial Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: PRAVASTATIN SODIUM
Outcome Measures for this Clinical Trial
Primary 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 Measures
- To compare the risk of nonfatal MI or coronary heart disease death between pravastatin and atorvastatin, and gatifloxacin and placebo.
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Bristol-Myers Squibb
Additional Information
Information obtained from ClinicalTrials.gov on October 15, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00382460
Study ID Number: CV123-229
ClinicalTrials.gov Identifier: NCT00382460
Health Authority: United States: Food and Drug Administration
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