Clinical trial NCT00382460: Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)
Official title: Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Actue Coronary Syndromes
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-09-29
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: To demonstrate the clinical equivalence of pravastatin 40 mg and atorvastatin 80 mg in reducing death or major cardiovascular event after 2 years
measure: 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:
measure: To compare the risk of nonfatal MI or coronary heart disease death between pravastatin and atorvastatin, and gatifloxacin and placebo.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.