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Fluvastatin in the Therapy of Acute Coronary Syndrome

Primary Purpose

Coronary Disease, Myocardial Infarction

Status

Completed

Phase

Phase 4

Locations

Czech Republic

Study Type

Interventional

Intervention

Fluvastatin

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Coronary disease, Myocardial infarction, Statins

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Novartis

Outcomes

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

Full Information

NCT ID

NCT00171275

First Posted

September 12, 2005

Last Updated

July 15, 2010

Sponsor

Novartis

Collaborators

Ministry of Health, Czech Republic

1. Study Identification

Unique Protocol Identification Number

NCT00171275

Brief Title

Fluvastatin in the Therapy of Acute Coronary Syndrome

Official Title

Fluvastatin in the Therapy of Acute Coronary Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

November 2003 (undefined)

Primary Completion Date

February 2007 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

Collaborators

Ministry of Health, Czech Republic

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Disease, Myocardial Infarction

Keywords

Coronary disease, Myocardial infarction, Statins

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

1000 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Fluvastatin

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis

City

Praha

Country

Czech Republic

12. IPD Sharing Statement

Citations:

PubMed Identifier

20500832

Citation

Ostadal P, Alan D, Vejvoda J, Kukacka J, Macek M, Hajek P, Mates M, Kvapil M, Kettner J, Wiendl M, Aschermann O, Slaby J, Holm F, Telekes P, Horak D, Blasko P, Zemanek D, Veselka J, Cepova J. Fluvastatin in the first-line therapy of acute coronary syndrome: results of the multicenter, randomized, double-blind, placebo-controlled trial (the FACS-trial). Trials. 2010 May 25;11:61. doi: 10.1186/1745-6215-11-61.

Results Reference

derived

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Fluvastatin in the Therapy of Acute Coronary Syndrome

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