Condition category
Circulatory System
Date applied
21/03/2005
Date assigned
22/03/2005
Last edited
11/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Petr Ostadal

ORCID ID

Contact details

Dept. of Cardiology
University Hospital Motol
V Uvalu 84
Prague
150 18
Czech Republic

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00171275

Protocol/serial number

CXU0320BCZ01

Study information

Scientific title

Acronym

FACS

Study hypothesis

The primary objective of the FACS trial is to demonstrate that statin therapy, when started immediately after hospital admission for ACS, results in reduction of inflammation and improvement of prognosis.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute coronary syndrome (ACS)

Intervention

Patients are randomized at admission to 80 mg fluvastatin (Lescol XL) or to placebo immediately orally (po) and then once daily for 30 days. Patients are followed up for 360 days.

Intervention type

Drug

Phase

Not Specified

Drug names

Fluvastatin

Primary outcome measures

Influence of fluvastatin therapy on levels of inflammatory markers (CRP and interleukin-6) and on pregnancy associated plasma protein A (PAPP-A)

Secondary outcome measures

A combined secondary endpoint is 30-day and one-year occurrence of death, nonfatal myocardial infarction, recurrent symptomatic ischemia, urgent revascularization, and cardiac arrest.

Overall trial start date

01/01/2003

Overall trial end date

01/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Eligible patients with ST elevation ACS must have resting chest pain less than 12 hours before admission and either >1 mm ST-segment elevation in 2 or more continuous leads or new left bundle branch block on electrocardiogram (ECG). Those with non-ST elevation ACS must have resting chest pain during the previous 48 hours and either >1 mm ST segment depression or negative T waves in 2 or more continuous leads.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/01/2003

Recruitment end date

01/01/2004

Locations

Countries of recruitment

Czech Republic, Slovakia

Trial participating centre

Dept. of Cardiology
Prague
150 18
Czech Republic

Sponsor information

Organisation

Novartis Pharma CR s.r.o. and Czech Ministry of Health

Sponsor details

Nagano III
U Nakladoveho Nadrazi 10
Prague
130 00
Czech Republic

Sponsor type

Industry

Website

Funders

Funder type

Government

Funder name

Grant from the Czech Ministry of Health, No. 00000064203

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Novartis Pharma CR s.r.o.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15790413
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20500832

Publication citations

  1. Results

    Ostadal P, Alan D, Hajek P, Vejvoda J, Mates M, Blasko P, Veselka J, Kvapil M, Kettner J, Wiendl M, Aschermann O, Slaby J, Nemecek E, Holm F, Rac M, Macek M, Cepova J, Fluvastatin in the therapy of acute coronary syndrome: Rationale and design of a multicenter, randomized, double-blind, placebo-controlled trial (The FACS Trial)[ISRCTN81331696]., Curr Control Trials Cardiovasc Med, 2005, 6, 1, 4, doi: 10.1186/1468-6708-6-4.

  2. Results

    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, 11, 61, doi: 10.1186/1745-6215-11-61.

Additional files

Editorial Notes