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
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Sponsor:
Tuen Mun Hospital
Collaborator:
AstraZeneca
Information provided by:
Tuen Mun Hospital
Tracking Information | ||||
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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 |
endothelial activation markers [ Time Frame: 12 months ] | |||
Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00371501 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
72 | |||
Original Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |