Official Title: “Fluvastatin in the Therapy of Acute Coronary Syndrome”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Fluvastatin

Primary Measures

• Change from baseline in circulating markers of inflammation after 4 weeks and after 52 weeks

Secondary Measures

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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171275

Study ID Number: CXUO320BCZ01

ClinicalTrials.gov Identifier: NCT00171275

Health Authority: Czech Republic: State Institute for Drug Control