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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00382460

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 IV

Drug Information available for: Pravastatin Pravastatin sodium Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Dose Comparison, Factorial Assignment, Efficacy Study
Official Title:	Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

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:	January 2001

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

No Contacts or Locations Provided

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Publications indexed to this study:

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.

Study ID Numbers:	CV123-229, TIMI22
Study First Received:	September 27, 2006
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00382460
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Pravastatin
Atorvastatin

Additional relevant MeSH terms:

Antimetabolites
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Syndrome
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009