Clinical trial NCT00371501: Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus
Official title: Low Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atherosclerosis
Thromboembolism
Systemic Lupus Erythematosus
Keywords: lupus
atherosclerosis
thrombosis
statin
lipid
Lead sponsor: Tuen Mun Hospital
Sponsor class: OTHER_GOV
Collaborators: name: AstraZeneca
First posted: 2006-09-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus (SLE).

Detailed description: To study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus. Subclinical atherosclerosis is assessed by ultrasound study of the carotid vessels and CT scan of the coronary arteries for calcium scores. Blood markers of endothelial activation will also be studied.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years
2. Fulfillment of at least 4 of the American College of Rheumatology (ACR) criteria for SLE
3. Presence of any two of the following risk factors:

   * SLE duration of \>= 5 years
   * Postmenopausal
   * Age \>= 40 years
   * Diabetes mellitus
   * Hypertension (140/90 mmHg)
   * Serum low density lipoprotein (LDL) level \>= 2.6 mmol/L or total cholesterol \>= 5.5 mmol/L
   * Obesity (body mass index \>= 27 kg/m2)
   * Chronic current smoker
   * Positive antiphospholipid antibodies
   * Renal function impairment
   * Persistent proteinuria \>= 1 gm/day for \>= 6 months
4. Informed consent obtained

Exclusion Criteria:

1. Patients with known allergy to aspirin, or any other non-steroidal anti-inflammatory drugs (NSAIDs), or statins
2. Patient with a history of severe gastrointestinal intolerance to aspirin (e.g., gastrointestinal bleeding) or other NSAIDs
3. Patients with history of arterial or venous thromboembolism
4. Patients receiving aspirin or other anti-platelet agents
5. Patients receiving long-term non-aspirin NSAIDs
6. Patients receiving anticoagulation therapy (e.g., warfarin)
7. Patients with history of intolerance or allergy to the statins
8. Pregnant or lactating women

Primary outcomes:
measure: endothelial activation markers
timeFrame: 12 months
Secondary outcomes:
measure: carotid intima media thickness
timeFrame: 24 months
measure: coronary Agatston score
timeFrame: 60 months
measure: Thrombotic events
timeFrame: 60 months
measure: adverse events
timeFrame: 60 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
Study officials:
affiliation: Department of Medicine, Tuen Mun Hospital, Hong Kong
name: CC Mok, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mok CC, Wong CK, To CH, Lai JP, Lam CS. Effects of rosuvastatin on vascular biomarkers and carotid atherosclerosis in lupus: a randomized, double-blind, placebo-controlled trial. Arthritis Care Res (Hoboken). 2011 Jun;63(6):875-83. doi: 10.1002/acr.20440.