- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00371501
Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus
September 15, 2010 updated by: Tuen Mun Hospital
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).
Study Overview
Status
Completed
Intervention / Treatment
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
Enrollment (Actual)
72
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, Hong Kong
- Tuen Mun Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age > 18 years
- Fulfillment of at least 4 of the American College of Rheumatology (ACR) criteria for SLE
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
- Informed consent obtained
Exclusion Criteria:
- Patients with known allergy to aspirin, or any other non-steroidal anti-inflammatory drugs (NSAIDs), or statins
- Patient with a history of severe gastrointestinal intolerance to aspirin (e.g., gastrointestinal bleeding) or other NSAIDs
- Patients with history of arterial or venous thromboembolism
- Patients receiving aspirin or other anti-platelet agents
- Patients receiving long-term non-aspirin NSAIDs
- Patients receiving anticoagulation therapy (e.g., warfarin)
- Patients with history of intolerance or allergy to the statins
- Pregnant or lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: treatment arm 1
|
10mg/day
Other Names:
|
Placebo Comparator: Treatment arm 2
|
placebo
one tablet/day
|
Active Comparator: treatment arm 3
aspirin
|
80mg/day
|
Placebo Comparator: treatment arm 4
placebo
|
placebo
one tablet/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
endothelial activation markers
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
carotid intima media thickness
Time Frame: 24 months
|
24 months
|
coronary Agatston score
Time Frame: 60 months
|
60 months
|
Thrombotic events
Time Frame: 60 months
|
60 months
|
adverse events
Time Frame: 60 months
|
60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: CC Mok, MD, FRCP, Department of Medicine, Tuen Mun Hospital, Hong Kong
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
September 1, 2006
First Submitted That Met QC Criteria
September 1, 2006
First Posted (Estimate)
September 4, 2006
Study Record Updates
Last Update Posted (Estimate)
September 16, 2010
Last Update Submitted That Met QC Criteria
September 15, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Autoimmune Diseases
- Connective Tissue Diseases
- Embolism and Thrombosis
- Lupus Erythematosus, Systemic
- Thromboembolism
- Atherosclerosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Aspirin
- Rosuvastatin Calcium
Other Study ID Numbers
- HARECCTR0500059
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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