Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus

• endothelial activation markers
• intimal thickness of carotid artery
• coronary calcium scores

• carotid intima media thickness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• coronary Agatston score [ Time Frame: 60 months ] [ Designated as safety issue: No ]
• Thrombotic events [ Time Frame: 60 months ] [ Designated as safety issue: No ]
• adverse events [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]

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).

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.

• Atherosclerosis
• Thromboembolism
• Systemic Lupus Erythematosus

• Drug: Rosuvastatin
  10mg/day
  Other Name: Crestor
• Drug: placebo
  one tablet/day
  Other Name: placebo
• Drug: aspirin
  80mg/day
  Other Name: aspirin
• Drug: placebo
  placebo
  Other Name: placebo

• Active Comparator: treatment arm 1
  Intervention: Drug: Rosuvastatin
• Placebo Comparator: Treatment arm 2
  Intervention: Drug: placebo
• Active Comparator: treatment arm 3
  aspirin
  Intervention: Drug: aspirin
• Placebo Comparator: treatment arm 4
  placebo
  Intervention: Drug: placebo

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