Contact information
Type
Scientific
Primary contact
Dr Wojciech Plazak
ORCID ID
Contact details
Pradnicka Str 80
Krakow
31-202
Poland
+48 (0)604 90 33 99
wplazak@szpitaljp2.krakow.pl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N40201231/0460
Study information
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
Acronym
Atorvastatin-SLE
Study hypothesis
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
Ethical Committee of the Jagiellonian University in Krakow, Poland, approved on the 12th January 2006 (ref: KBET/2/L/2006)
Study design
Prospective randomised double-masked placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Atorvastatin
Primary outcome measures
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 trial start date
01/01/2006
Overall trial end date
10/11/2010
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
01/01/2006
Recruitment end date
10/11/2010
Locations
Countries of recruitment
Poland
Trial participating centre
Pradnicka Str 80
Krakow
31-202
Poland
Sponsor information
Organisation
Polish Ministry of Science and Higher Education (Poland)
Sponsor details
Hoza Str 20
Warszawa
00-529
Poland
+48 (0)22 529 27 18
sekretariat.minister@nauka.gov.pl
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Polish Ministry of Science and Higher Education (Poland) (ref: N40201231/0460)
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