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
  Purpose

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
Atherosclerosis
Thromboembolism
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
10mg/day
Other Name: Crestor
Placebo Comparator: Treatment arm 2 Drug: placebo
one tablet/day
Other Name: placebo
Active Comparator: treatment arm 3
aspirin
Drug: aspirin
80mg/day
Other Name: aspirin
Placebo Comparator: treatment arm 4
placebo
Drug: placebo
placebo
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371501

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

No publications provided by Tuen Mun Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CC Mok, Tuen Mun Hospital, Hong Kong
ClinicalTrials.gov 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:
lupus
atherosclerosis
thrombosis
statin
lipid

Additional relevant MeSH terms:
Atherosclerosis
Lupus Erythematosus, Systemic
Thromboembolism
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Embolism and Thrombosis
Thrombosis
Aspirin
Rosuvastatin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014