Condition category
Musculoskeletal Diseases
Date applied
19/01/2011
Date assigned
18/02/2011
Last edited
18/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.nauka.gov.pl

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

Publication citations

Additional files

Editorial Notes