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

This study has been completed.
Information provided by:
Tuen Mun Hospital Identifier:
First received: September 1, 2006
Last updated: September 15, 2010
Last verified: September 2010
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).

Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: Rosuvastatin
Drug: placebo
Drug: aspirin
Phase 4

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

Resource links provided by NLM:

Further study details as provided by Tuen Mun Hospital:

Primary Outcome Measures:
  • endothelial activation markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • carotid intima media thickness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • coronary Agatston score [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Thrombotic events [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: June 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: treatment arm 1 Drug: Rosuvastatin
Other Name: Crestor
Placebo Comparator: Treatment arm 2 Drug: placebo
one tablet/day
Active Comparator: treatment arm 3
Drug: aspirin
Placebo Comparator: treatment arm 4
Drug: placebo

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00371501

Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Tuen Mun Hospital
Principal Investigator: CC Mok, MD, FRCP Department of Medicine, Tuen Mun Hospital, Hong Kong
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: CC Mok, Tuen Mun Hospital, Hong Kong Identifier: NCT00371501     History of Changes
Other Study ID Numbers: HARECCTR0500059 
Study First Received: September 1, 2006
Last Updated: September 15, 2010
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Tuen Mun Hospital:

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Arterial Occlusive Diseases
Autoimmune Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Embolism and Thrombosis
Immune System Diseases
Vascular Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents processed this record on May 30, 2016