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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Tuen Mun Hospital
ClinicalTrials.gov Identifier:
NCT00371501
First received: September 1, 2006
Last updated: September 15, 2010
Last verified: September 2010
History of Changes

September 1, 2006
September 15, 2010
June 2006
December 2009   (final data collection date for primary outcome measure)
endothelial activation markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • intimal thickness of carotid artery
  • coronary calcium scores
  • endothelial activation markers
Complete list of historical versions of study NCT00371501 on ClinicalTrials.gov Archive Site
  • 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 ]
clinical thromboembolic events
Not Provided
Not Provided
 
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
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).
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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Atherosclerosis
  • Thromboembolism
  • Systemic Lupus Erythematosus
  • Drug: Rosuvastatin
    10mg/day
    Other Name: Crestor
  • Drug: placebo
    one tablet/day
  • Drug: aspirin
    80mg/day
  • Drug: placebo
    placebo
  • Active Comparator: treatment arm 1
    Intervention: Drug: Rosuvastatin
  • Placebo Comparator: Treatment arm 2
    Intervention: Drug: placebo
  • Active Comparator: treatment arm 3
    aspirin
    Intervention: Drug: aspirin
  • Placebo Comparator: treatment arm 4
    placebo
    Intervention: Drug: placebo
Mok CC, Wong CK, To CH, Lai JP, Lam CS. Effects of rosuvastatin on vascular biomarkers and carotid atherosclerosis in lupus: a randomized, double-blind, placebo-controlled trial. Arthritis Care Res (Hoboken). 2011 Jun;63(6):875-83. doi: 10.1002/acr.20440.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT00371501
HARECCTR0500059
Yes
Not Provided
Not Provided
CC Mok, Tuen Mun Hospital, Hong Kong
Tuen Mun Hospital
AstraZeneca
Principal Investigator: CC Mok, MD, FRCP Department of Medicine, Tuen Mun Hospital, Hong Kong
Tuen Mun Hospital
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP