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

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

Tracking Information

• First Submitted Date: September 1, 2006
• First Posted Date: September 4, 2006
• Last Update Posted Date: September 16, 2010
• Study Start Date: June 2006
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 15, 2010): endothelial activation markers [ Time Frame: 12 months ]

Original Primary Outcome Measures (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 (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 (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: Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus
• 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention

Condition

• Atherosclerosis
• Thromboembolism
• Systemic Lupus Erythematosus

Intervention

• Drug: Rosuvastatin
  10mg/day
  Other Name: Crestor
• Drug: placebo
  one tablet/day
• Drug: aspirin
  80mg/day
• Drug: placebo
  placebo

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 15, 2010): 72
• Original Enrollment (submitted: September 1, 2006): 80
• Actual Study Completion Date: December 2009
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Hong Kong

Administrative Information

• NCT Number: NCT00371501
• Other Study ID Numbers: HARECCTR0500059
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: CC Mok, Tuen Mun Hospital, Hong Kong
• Study Sponsor: Tuen Mun Hospital
• Collaborators: AstraZeneca

Investigators

• Principal Investigator: CC Mok, MD, FRCP; Department of Medicine, Tuen Mun Hospital, Hong Kong

• PRS Account: Tuen Mun Hospital
• Verification Date: September 2010