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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Low Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled Trial

Conditions
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Atherosclerosis, Thromboembolism, Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: placebo
* Drug: aspirin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Fulfillment of at least 4 of the American College of Rheumatology (ACR) criteria for SLE 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 Informed consent obtained Exclusion Criteria: Patients with known allergy to aspirin, or any other non-steroidal anti-inflammatory drugs (NSAIDs), or statins Patient with a history of severe gastrointestinal intolerance to aspirin (e.g., gastrointestinal bleeding) or other NSAIDs Patients with history of arterial or venous thromboembolism Patients receiving aspirin or other anti-platelet agents Patients receiving long-term non-aspirin NSAIDs Patients receiving anticoagulation therapy (e.g., warfarin) Patients with history of intolerance or allergy to the statins Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment arm 1<br> | Drug: Rosuvastatin<br>* 10mg/day<br>* Other names: Crestor;|
| Placebo Comparator: Treatment arm 2<br> | Drug: placebo<br>* one tablet/day<br>|
| Active Comparator: treatment arm 3<br>aspirin | Drug: aspirin<br>* 80mg/day<br>|
| Placebo Comparator: treatment arm 4<br>placebo | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial activation markers |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carotid intima media thickness |  | 24 months | 
| coronary Agatston score |  | 60 months | 
| Thrombotic events |  | 60 months | 
| adverse events |  | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lupus, atherosclerosis, thrombosis, statin, lipid