Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22) - Tabular View

Tracking Information
First Received Date ^ICMJE	September 27, 2006
Last Updated Date	June 27, 2008
Start Date ^ICMJE	January 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: September 27, 2006)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00382460 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 27, 2006)	To compare the risk of nonfatal MI or coronary heart disease death between pravastatin and atorvastatin, and gatifloxacin and placebo.
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)
Official Title ^ICMJE	Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)
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.
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double-Blind, Dose Comparison, Factorial Assignment, Efficacy Study
Condition ^ICMJE	Actue Coronary Syndromes
Intervention ^ICMJE	Drug: PRAVASTATIN SODIUM
Study Arms / Comparison Groups
Publications *	Giraldez RR, Giugliano RP, Mohanavelu S, Murphy SA, McCabe CH, Cannon CP, Braunwald E. Baseline low-density lipoprotein cholesterol is an important predictor of the benefit of intensive lipid-lowering therapy: a PROVE IT-TIMI 22 (Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis In Myocardial Infarction 22) analysis. J Am Coll Cardiol. 2008 Sep 9;52(11):914-20. Miller M, Cannon CP, Murphy SA, Qin J, Ray KK, Braunwald E; PROVE IT-TIMI 22 Investigators. Impact of triglyceride levels beyond low-density lipoprotein cholesterol after acute coronary syndrome in the PROVE IT-TIMI 22 trial. J Am Coll Cardiol. 2008 Feb 19;51(7):724-30.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	4000
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00382460
Responsible Party
Study ID Numbers ^ICMJE	CV123-229, TIMI22
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	September 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP