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.

Completed

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis

Prague, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluvastatin

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

Ministry of Health, Czech Republic

Registry information

Important dates

Study start: 2003
Primary completion: 2007
First posted: Sep 15, 2005
Registry last updated: Jul 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed