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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tuen Mun Hospital
• Collaborator: AstraZeneca
• Treatments: Aspirin; Rosuvastatin Calcium

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