Atorvastatin treatment in Systemic Lupus Erythematosus patients
| ISRCTN | ISRCTN51612701 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51612701 |
| Protocol serial number | N40201231/0460 |
| Sponsor | Polish Ministry of Science and Higher Education (Poland) |
| Funder | Polish Ministry of Science and Higher Education (Poland) (ref: N40201231/0460) |
- Submission date
- 19/01/2011
- Registration date
- 18/02/2011
- Last edited
- 18/02/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Wojciech Plazak
Scientific
Scientific
Pradnicka Str 80
Krakow
31-202
Poland
| Phone | +48 (0)604 90 33 99 |
|---|---|
| wplazak@szpitaljp2.krakow.pl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised double-masked placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Influence of Atorvastatin on coronary calcifications and myocardial perfusion defects in Systemic Lupus Erythematosus patients: a prospective, randomised, double-masked, placebo-controlled study |
| Study acronym | Atorvastatin-SLE |
| Study objectives | This study was conducted to determine the effect of atorvastatin treatment on multidetector computed tomography (MDCT)-based coronary calcium scoring and single photon emission computed tomography (SPECT)-assessed myocardial perfusion abnormalities in systemic lupus erythematosus (SLE) patients free of cardiovascular disease clinical symptoms. |
| Ethics approval(s) | Ethical Committee of the Jagiellonian University in Krakow, Poland, approved on the 12th January 2006 (ref: KBET/2/L/2006) |
| Health condition(s) or problem(s) studied | Systemic lupus erythematosus |
| Intervention | Atorvastatin treatment (40 mg/day) versus placebo. Total duration of treatment: 1 year. One year follow-up period. |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Atorvastatin |
| Primary outcome measure(s) |
Measured at 0 and 12 months: |
| Key secondary outcome measure(s) |
Measured at 0, 3, 6, 12 months: |
| Completion date | 10/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Patients aged 20 - 73, either sex 2. Fulfilled at least 4 American College of Rheumatology (ACR) classification criteria for SLE 3. In stable clinical conditions (no need for immunosuppressive therapy intensification, i.e. current immunosuppressive drug dose increase or introduction of an additional immunosuppressive drug within last 3 months) |
| Key exclusion criteria | 1. Known cancer 2. Clinical symptoms of coronary heart disease or heart failure (New York Heart Association [NYHA] III or IV class) 3. Renal failure (creatinine clearance less than 30 ml/min) 4. Respiratory failure |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 10/11/2010 |
Locations
Countries of recruitment
- Poland
Study participating centre
Pradnicka Str 80
Krakow
31-202
Poland
31-202
Poland
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
