NCT00171275

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Last Updated

July 16, 2010

Status Verified

July 1, 2010

Enrollment Period

3.3 years

First QC Date

September 12, 2005

Last Update Submit

July 15, 2010

Conditions

Coronary DiseaseMyocardial Infarction

Keywords

Coronary diseaseMyocardial infarctionStatins

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

FluvastatinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute coronary syndrome
  • Adults, 18 years and older

You may not qualify if:

  • History of lipid lowering therapy less than 30 days before index event
  • Pregnancy and nursing
  • Subject younger than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Prague, Czechia

Location

Related Publications (1)

  • 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.

    PMID: 20500832DERIVED

MeSH Terms

Conditions

Coronary DiseaseMyocardial Infarction

Interventions

Fluvastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

November 1, 2003

Primary Completion

February 1, 2007

Last Updated

July 16, 2010

Record last verified: 2010-07

Locations

CZ(1)