Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

Conditions

Actue Coronary Syndromes

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.

Mengozzi A, Tricò D, Natali A.

2020-06-263 citations

10.1186/s13063-020-04511-y

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.

Bangalore S, Qin J, Sloan S, Murphy SA, Cannon CP, PROVE IT-TIMI 22 Trial Investigators.

2010-11-08160 citations

10.1161/circulationaha.109.905687

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.

Gibson CM, Pride YB, Hochberg CP, Sloan S, Sabatine MS, Cannon CP, TIMI Study Group.

2009-12-0194 citations

10.1016/j.jacc.2009.09.010

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.

Giraldez RR, Giugliano RP, Mohanavelu S, Murphy SA, McCabe CH, Cannon CP, Braunwald E.

2008-09-0153 citations

10.1016/j.jacc.2008.05.046

Interventions

DRUGPRAVASTATIN SODIUM

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
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

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

Outcome results

None listed