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OpenTrials
Completed

NCT Number: NCT00382460

Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

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.

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Key information

Conditions

Actue Coronary Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRAVASTATIN SODIUM

Drug

Primary outcomes

  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 outcomes

  1. To compare the risk of nonfatal MI or coronary heart disease death between pravastatin and atorvastatin, and gatifloxacin and placebo.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2000
Primary completion
2003
Study completion
2003
First posted
Sep 29, 2006
Registry last updated
Apr 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.