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

Tuen Mun Hospital

Status and phase: Completed; Phase 4

Conditions: Thromboembolism; Atherosclerosis; Systemic Lupus Erythematosus

Treatments: Drug: placebo; Drug: aspirin; Drug: Rosuvastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00371501

HARECCTR0500059

Details and patient eligibility

About

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).

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 4 patient groups, including a placebo group

treatment arm 1

Active Comparator group

Treatment:

Drug: Rosuvastatin

Treatment arm 2

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

treatment arm 3

Active Comparator group

Description:

aspirin

Treatment:

Drug: aspirin

treatment arm 4

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo

Drug: placebo