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

Low Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00371501

Enrollment

Registered

2006-09-04

Start date

2006-06-30

Completion date

2009-12-31

Last updated

2010-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Systemic Lupus Erythematosus, Thromboembolism

Keywords

lupus, atherosclerosis, thrombosis, statin, lipid

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.

Interventions

DRUGRosuvastatin

10mg/day

DRUGplacebo

one tablet/day

DRUGaspirin

80mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
endothelial activation markers	12 months

Secondary

Measure	Time frame
carotid intima media thickness	24 months
coronary Agatston score	60 months
Thrombotic events	60 months
adverse events	60 months

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026