Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00382460
First received: September 27, 2006
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional 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, TIMI22
Study First Received: September 27, 2006
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atorvastatin
Pravastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014