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Fluvastatin in the Therapy of Acute Coronary Syndrome

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Czech Republic
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171275
First received: September 12, 2005
Last updated: July 15, 2010
Last verified: July 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Coronary Disease
Myocardial Infarction
 Drug: Fluvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Fluvastatin in the Therapy of Acute Coronary Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

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

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

Estimated Enrollment: 1000
Study Start Date: November 2003
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171275

Locations
Czech Republic
Novartis
Praha, Czech Republic
Sponsors and Collaborators
Novartis
Ministry of Health, Czech Republic
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00171275     History of Changes
Other Study ID Numbers: CXUO320BCZ01
Study First Received: September 12, 2005
Last Updated: July 15, 2010
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Novartis:
Coronary disease
Myocardial infarction
Statins

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Necrosis
 Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Fluvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013