Fluvastatin in the therapy of acute coronary syndrome
| ISRCTN | ISRCTN81331696 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81331696 |
| ClinicalTrials.gov (NCT) | NCT00171275 |
| Protocol serial number | CXU0320BCZ01 |
| Sponsor | Novartis Pharma CR s.r.o. |
| Funders | Ministerstvo Zdravotnictví Ceské Republiky, Novartis |
- Submission date
- 21/03/2005
- Registration date
- 22/03/2005
- Last edited
- 16/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Petr Ostadal
Scientific
Scientific
Dept. of Cardiology
University Hospital Motol
V Uvalu 84
Prague
150 18
Czech Republic
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fluvastatin |
| Primary outcome measure(s) |
Influence of fluvastatin therapy on levels of inflammatory markers (CRP and interleukin-6) and on pregnancy associated plasma protein A (PAPP-A) |
| Key secondary outcome measure(s) |
A combined secondary endpoint is 30-day and one-year occurrence of death, nonfatal myocardial infarction, recurrent symptomatic ischemia, urgent revascularization, and cardiac arrest. |
| Completion date | 01/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Czech Republic
- Slovakia
Study participating centre
Dept. of Cardiology
Prague
150 18
Czech Republic
150 18
Czech Republic
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| 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 |
Editorial Notes
16/01/2020: Internal review.
