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

Phase 4

Completed

• Conditions: Atherosclerosis; Thromboembolism; Systemic Lupus Erythematosus
• Interventions: Drug: placebo; Drug: Rosuvastatin; Drug: aspirin

• Registration Number: NCT00371501
• Lead Sponsor: Tuen Mun Hospital

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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-09-01
• Study First Submitted QC: 2006-09-01
• Study First Posted: 2006-09-04
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-15
• Last Update Posted: 2010-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment arm 2	placebo	-
treatment arm 4	placebo	placebo
treatment arm 1	Rosuvastatin	-
treatment arm 3	aspirin	aspirin

Primary Outcome Measures

Name	Time	Method
endothelial activation markers	12 months

Secondary Outcome Measures

Name	Time	Method
carotid intima media thickness	24 months
coronary Agatston score	60 months
Thrombotic events	60 months
adverse events	60 months

Trial Locations

Locations (1)

Tuen Mun Hospital; 🇭🇰 Hong Kong, Hong Kong