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

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ClinicalTrials.gov Identifier: NCT00371501
Recruitment Status : Completed
First Posted : September 4, 2006
Last Update Posted : September 16, 2010
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Tuen Mun Hospital

Tracking Information
First Submitted Date  ICMJE September 1, 2006
First Posted Date  ICMJE September 4, 2006
Last Update Posted Date September 16, 2010
Study Start Date  ICMJE June 2006
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
endothelial activation markers [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2006)
  • intimal thickness of carotid artery
  • coronary calcium scores
  • endothelial activation markers
Change History Complete list of historical versions of study NCT00371501 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
  • carotid intima media thickness [ Time Frame: 24 months ]
  • coronary Agatston score [ Time Frame: 60 months ]
  • Thrombotic events [ Time Frame: 60 months ]
  • adverse events [ Time Frame: 60 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2006)
clinical thromboembolic events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus
Official Title  ICMJE Low Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Atherosclerosis
  • Thromboembolism
  • Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: Rosuvastatin
    10mg/day
    Other Name: Crestor
  • Drug: placebo
    one tablet/day
  • Drug: aspirin
    80mg/day
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2010)
72
Original Enrollment  ICMJE
 (submitted: September 1, 2006)
80
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00371501
Other Study ID Numbers  ICMJE HARECCTR0500059
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CC Mok, Tuen Mun Hospital, Hong Kong
Study Sponsor  ICMJE Tuen Mun Hospital
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: CC Mok, MD, FRCP Department of Medicine, Tuen Mun Hospital, Hong Kong
PRS Account Tuen Mun Hospital
Verification Date September 2010

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