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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00731302 |
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Date of registration:
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05/08/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Aspirin Resistance in Systemic Lupus Erythematosus (SLE)
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Scientific title:
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Vascular Damage in Systemic Lupus Erythematosus (SLE) |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00731302 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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C M Stein, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Written Informed consent.
- Age >18 yrs.
- SLE meeting ACR criteria {Tan, Cohen, et al. 1982 1482 /id} for at least 6 months.(SLE
group)
- Stable disease activity as evidenced by no change in immunosuppressive therapy in the
past 1 month.
- If female of childbearing potential must use an effective method of birth control
Exclusion criteria.
- Renal disease (creatinine >1.5 mg/dL, dialysis, 2+ or more proteinuria)
- Previous or current history of peptic ulcer disease or gastrointestinal bleed.
- Previous or current thromboembolic or ischemic cardiovascular event (stroke,
myocardial infarction, angina) - can do aspirin part of study.
- Currently taking an anticoagulant or antiplatelet agent (besides aspirin).
- Thrombocytopenia (platelet count <135,000)
- Pregnancy
- Allergy to aspirin, NSAIDs
- NSAIDs in the previous week
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: aspirin and meloxicam
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Primary Outcome(s)
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thromboxane
[Time Frame: after aspirin and after aspirin plus meloxicam]
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Secondary ID(s)
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HL65082
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R01HL065082
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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