Status:
COMPLETED
Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus
Lead Sponsor:
Tuen Mun Hospital
Collaborating Sponsors:
AstraZeneca
Conditions:
Atherosclerosis
Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00371501
Start Date
June 1 2006
End Date
December 1 2009
Last Update
September 16 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tuen Mun Hospital
Hong Kong, Hong Kong