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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 16, 2014