Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

NCT00382460 | Completed Phase 4

• 2 other identifiers: CV123-229TIMI22
• Study Type: interventional
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Actue Coronary Syndromes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

Interventions

PRAVASTATIN SODIUM DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalization for MI or high risk unstable angina within the last 10 days.
• Total cholesterol 240 mg/dl or greater.
• Stabilized post ACS

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Publications (10)

• Mengozzi A, Trico D, Natali A. A novel method for interpreting survival analysis data: description and test on three major clinical trials on cardiovascular prevention. Trials. 2020 Jun 26;21(1):578. doi: 10.1186/s13063-020-04511-y.

  PMID: 32586346 DERIVED

• Bonaca MP, O'Malley RG, Jarolim P, Scirica BM, Murphy SA, Conrad MJ, Cannon CP, White HD, Braunwald E, Morrow DA, Sabatine MS. Serial Cardiac Troponin Measured Using a High-Sensitivity Assay in Stable Patients With Ischemic Heart Disease. J Am Coll Cardiol. 2016 Jul 19;68(3):322-323. doi: 10.1016/j.jacc.2016.04.046. No abstract available.

  PMID: 27417011 DERIVED

• Nazer B, Ray KK, Murphy SA, Gibson CM, Cannon CP. Urinary albumin concentration and long-term cardiovascular risk in acute coronary syndrome patients: a PROVE IT-TIMI 22 substudy. J Thromb Thrombolysis. 2013 Oct;36(3):233-9. doi: 10.1007/s11239-012-0853-0.

  PMID: 23212806 DERIVED

• 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. doi: 10.1016/j.ahj.2011.02.014. Epub 2011 May 11.

  PMID: 21641362 DERIVED

• 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;4(3):328-36. doi: 10.1161/CIRCOUTCOMES.110.957720. Epub 2011 Apr 12.

  PMID: 21487089 DERIVED

• 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. doi: 10.1093/eurheartj/ehr032. Epub 2011 Feb 22.

  PMID: 21345849 DERIVED

• 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. doi: 10.1161/CIRCULATIONAHA.109.905687. Epub 2010 Nov 8.

  PMID: 21060068 DERIVED

• 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. doi: 10.1016/j.jacc.2009.09.010.

  PMID: 19958964 DERIVED

• 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. doi: 10.1016/j.jacc.2008.05.046.

  PMID: 18772061 DERIVED

• 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. doi: 10.1016/j.jacc.2007.10.038.

  PMID: 18279736 DERIVED

MeSH Terms

Interventions

Pravastatin

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 27, 2006
• First Posted: September 29, 2006
• Study Start: November 1, 2000
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2003
• Last Updated: April 15, 2011

Record last verified: 2011-04