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NCT00171275 Clinical Trial

Fluvastatin in the Therapy of Acute Coronary Syndrome

Myocardial Infarction Clinical Trial

Official title:
Fluvastatin in the Therapy of Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00171275
Other study ID # CXUO320BCZ01
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated July 15, 2010
Start date November 2003

Study information
Verified date July 2010
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Czech Republic: State Institute for Drug Control
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Fluvastatin

Locations
Country Name City State
Czech Republic Novartis Praha

Sponsors (2)
Lead Sponsor Collaborator
Novartis Ministry of Health, Czech Republic

Country where clinical trial is conducted

Czech Republic, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in circulating markers of inflammation after 4 weeks and after 52 weeks
Secondary Occurrence of death, nonfatal myocardial infarction, cardiac arrest with resuscitation, recurrent symptomatic ischemia, and urgent revascularization after 4 weeks and after 52 weeks
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