Fluvastatin in the therapy of acute coronary syndrome

ISRCTN	ISRCTN81331696
DOI	https://doi.org/10.1186/ISRCTN81331696
ClinicalTrials.gov number	NCT00171275
Secondary identifying numbers	CXU0320BCZ01

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Petr Ostadal
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Fluvastatin in the therapy of acute coronary syndrome
Study acronym	FACS
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Fluvastatin
Primary outcome measure	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 study start date	01/01/2003
Completion date	01/01/2004

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	1000
Key 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.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/01/2003
Date of final enrolment	01/01/2004

Dept. of Cardiology

Prague
150 18
Czech Republic

Novartis Pharma CR s.r.o.
Industry

Nagano III
U Nakladoveho Nadrazi 10
Prague
130 00
Czech Republic

"ROR"	https://ror.org/02f9zrr09

Government

Ministerstvo Zdravotnictví Ceské Republiky
Government organisation / National government

Novartis
Government organisation / For-profit companies (industry)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	24/03/2005		Yes	No
Results article	results	25/05/2010		Yes	No

16/01/2020: Internal review.