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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00371501
• Date of registration: 01/09/2006
• Prospective Registration: No
• Primary sponsor: Tuen Mun Hospital
• Public title: Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus
• Scientific title: Low Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled Trial
• Date of first enrolment: June 2006
• Target sample size: 72
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00371501
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
• Phase: Phase 4

Countries of recruitment

Hong Kong

Contacts

• Name: CC Mok, MD, FRCP
• Affiliation: Department of Medicine, Tuen Mun Hospital, Hong Kong

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Atherosclerosis

Systemic Lupus Erythematosus

Thromboembolism

Intervention(s)

Drug: Rosuvastatin

Drug: aspirin

Drug: placebo

Primary Outcome(s)

endothelial activation markers [Time Frame: 12 months]

Secondary Outcome(s)

Thrombotic events [Time Frame: 60 months]

carotid intima media thickness [Time Frame: 24 months]

coronary Agatston score [Time Frame: 60 months]

adverse events [Time Frame: 60 months]

Secondary ID(s)

HARECCTR0500059

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AstraZeneca