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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00371501
Recruitment Status : Completed
First Posted : September 4, 2006
Last Update Posted : September 16, 2010
Information provided by:
Tuen Mun Hospital

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).

Condition or disease Intervention/treatment Phase
Atherosclerosis Thromboembolism Systemic Lupus Erythematosus Drug: Rosuvastatin Drug: placebo Drug: aspirin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. endothelial activation markers [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. carotid intima media thickness [ Time Frame: 24 months ]
  2. coronary Agatston score [ Time Frame: 60 months ]
  3. Thrombotic events [ Time Frame: 60 months ]
  4. adverse events [ Time Frame: 60 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00371501

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Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Tuen Mun Hospital
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Principal Investigator: CC Mok, MD, FRCP Department of Medicine, Tuen Mun Hospital, Hong Kong
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: CC Mok, Tuen Mun Hospital, Hong Kong Identifier: NCT00371501    
Other Study ID Numbers: HARECCTR0500059
First Posted: September 4, 2006    Key Record Dates
Last Update Posted: September 16, 2010
Last Verified: September 2010
Keywords provided by Tuen Mun Hospital:
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Embolism and Thrombosis
Rosuvastatin Calcium
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents