Fluvastatin in the Therapy of Acute Coronary Syndrome

Phase 4

Completed

• Conditions: Coronary Disease; Myocardial Infarction

• Registration Number: NCT00171275
• Lead Sponsor: Novartis

Brief Summary

This study is to evaluate the safety and efficacy of fluvastatin versus placebo, dosed shortly after or immediately when the coronary event occurs.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2007-02
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-15
• Last Update Posted: 2010-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Acute coronary syndrome
• Adults, 18 years and older

Exclusion Criteria

• History of lipid lowering therapy less than 30 days before index event
• Pregnancy and nursing
• Subject younger than 18 years

Other inclusion and exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in circulating markers of inflammation after 4 weeks and after 52 weeks

Secondary Outcome Measures

Name	Time	Method
Occurrence of death, nonfatal myocardial infarction, cardiac arrest with resuscitation, recurrent symptomatic ischemia, and urgent revascularization after 4 weeks and after 52 weeks

Trial Locations

Locations (1)

Novartis; 🇨🇿 Praha, Czech Republic