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

Sponsor:	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

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:

Drug Information available for: Pravastatin Pravastatin sodium Atorvastatin Atorvastatin calcium

U.S. FDA Resources

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

No Contacts or Locations Provided

More Information

Additional 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

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wilson SR, Sabatine MS, Wiviott SD, Ray KK, De Lemos JA, Zhou S, Rifai N, Cannon CP, Morrow DA; TIMI Study Group. Assessment of adiponectin and the risk of recurrent cardiovascular events in patients presenting with an acute coronary syndrome: observations from the Pravastatin Or atorVastatin Evaluation and Infection Trial-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22). Am Heart J. 2011 Jun;161(6):1147-55.e1. Epub 2011 May 11.

Truong QA, Murphy SA, McCabe CH, Armani A, Cannon CP; TIMI Study Group. Benefit of intensive statin therapy in women: results from PROVE IT-TIMI 22. Circ Cardiovasc Qual Outcomes. 2011 May 1;4(3):328-36. Epub 2011 Apr 12.

Nazer B, Ray KK, Sloan S, Scirica B, Morrow DA, Cannon CP, Braunwald E. Prognostic utility of neopterin and risk of heart failure hospitalization after an acute coronary syndrome. Eur Heart J. 2011 Jun;32(11):1390-7. Epub 2011 Feb 22.

Bangalore S, Qin J, Sloan S, Murphy SA, Cannon CP; PROVE IT-TIMI 22 Trial Investigators. What is the optimal blood pressure in patients after acute coronary syndromes?: Relationship of blood pressure and cardiovascular events in the PRavastatin OR atorVastatin Evaluation and Infection Therapy-Thrombolysis In Myocardial Infarction (PROVE IT-TIMI) 22 trial. Circulation. 2010 Nov 23;122(21):2142-51. Epub 2010 Nov 8.

Gibson CM, Pride YB, Hochberg CP, Sloan S, Sabatine MS, Cannon CP; TIMI Study Group. Effect of intensive statin therapy on clinical outcomes among patients undergoing percutaneous coronary intervention for acute coronary syndrome. PCI-PROVE IT: A PROVE IT-TIMI 22 (Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis In Myocardial Infarction 22) Substudy. J Am Coll Cardiol. 2009 Dec 8;54(24):2290-5.

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.

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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012