Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

Actue Coronary Syndromes Clinical Trial

Official title:

Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382460
• Other study ID #: CV123-229
• Secondary ID: TIMI22
• Status: Completed
• Phase: Phase 4
• First received: September 27, 2006
• Last updated: April 7, 2011
• Start date: November 2000
• Est. completion date: December 2003

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Actue Coronary Syndromes

Intervention

Drug:
• PRAVASTATIN SODIUM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate the clinical equivalence of pravastatin 40 mg and atorvastatin 80 mg in reducing death or major cardiovascular event after 2 years
Primary	To demonstrate in subjects with ACS that Gatifloxacin is effective in reducing death or major cardiovascular event after 2 years, compared to placebo.
Secondary	To compare the risk of nonfatal MI or coronary heart disease death between pravastatin and atorvastatin, and gatifloxacin and placebo.

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm