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Fluvastatin in the Therapy of Acute Coronary Syndrome

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ClinicalTrials.gov Identifier: NCT00171275
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 16, 2010
Ministry of Health, Czech Republic
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Coronary Disease Myocardial Infarction Drug: Fluvastatin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Fluvastatin in the Therapy of Acute Coronary Syndrome
Study Start Date : November 2003
Primary Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Primary Outcome Measures :
  1. Change from baseline in circulating markers of inflammation after 4 weeks and after 52 weeks

Secondary Outcome Measures :
  1. Occurrence of death, nonfatal myocardial infarction, cardiac arrest with resuscitation, recurrent symptomatic ischemia, and urgent revascularization after 4 weeks and after 52 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171275

Czech Republic
Praha, Czech Republic
Sponsors and Collaborators
Ministry of Health, Czech Republic
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00171275     History of Changes
Other Study ID Numbers: CXUO320BCZ01
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: July 16, 2010
Last Verified: July 2010

Keywords provided by Novartis:
Coronary disease
Myocardial infarction

Additional relevant MeSH terms:
Myocardial Infarction
Acute Coronary Syndrome
Coronary Disease
Coronary Artery Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors