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

Atherosclerosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371501
• Other study ID #: HARECCTR0500059
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2006
• Last updated: September 15, 2010
• Start date: June 2006
• Est. completion date: December 2009

Study information

• Verified date: September 2010
• Source: Tuen Mun Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus
• Thromboembolism

Intervention

Drug:
• Rosuvastatin
10mg/day
• placebo
one tablet/day
• aspirin
80mg/day
• placebo
placebo

Locations

Country	Name	City	State
Hong Kong	Tuen Mun Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Tuen Mun Hospital	AstraZeneca

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial activation markers		12 months	No
Secondary	carotid intima media thickness		24 months	No
Secondary	coronary Agatston score		60 months	No
Secondary	Thrombotic events		60 months	No
Secondary	adverse events		60 months	Yes