Atorvastatin treatment in Systemic Lupus Erythematosus patients

ISRCTN	ISRCTN51612701
DOI	https://doi.org/10.1186/ISRCTN51612701
Secondary identifying numbers	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

Pradnicka Str 80
Krakow
31-202
Poland

Phone	+48 (0)604 90 33 99
Email	wplazak@szpitaljp2.krakow.pl

Study information

Study design	Prospective randomised double-masked placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Atorvastatin
Primary outcome measure	Measured at 0 and 12 months: 1. Calcium deposits in coronary arteries 2. Number of myocardial left ventricle segments with perfusion defects
Secondary outcome measures	Measured at 0, 3, 6, 12 months: 1. Symptoms of myocardial ischaemia 2. Need for reperfusion therapy 3. Deaths
Overall study start date	01/01/2006
Completion date	10/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Sponsor information

Polish Ministry of Science and Higher Education (Poland)
Government

Hoza Str 20
Warszawa
00-529
Poland

Phone	+48 (0)22 529 27 18
Email	sekretariat.minister@nauka.gov.pl
Website	http://www.nauka.gov.pl
"ROR"	https://ror.org/05dwvd537

Funders

Funder type

Government

Polish Ministry of Science and Higher Education (Poland) (ref: N40201231/0460)

No information available

Results and Publications

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