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Aspirin Resistance in Systemic Lupus Erythematosus (SLE) - NCT00731302-02215(Clinical Trial 235410)



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City:  Boston
State:  
MA
Zip Code: 02215
Conditions: Systemic Lupus Erythematosus
Purpose: This study examine whether patients with lupus respond to aspirin , and if not, if that is related to inflammation. We examine the ability of aspirin to inhibit the production of thromboxane in patients with lupus and controls and see if aspirin insensitive thromboxane production is inhibited by meloxicam.
Study summary: Premature cardiovascular disease is a major cause of mortality in patients with systemic lupus erythematosus (SLE) with the risk of myocardial infarction increased up to 50-fold. In addition to defining the mechanisms for accelerated atherosclerosis it is important to define the effects of drugs used to reduce cardiovascular risk in high-risk patients. Low dose aspirin, by inhibiting thromboxane A2 biosynthesis, has profound antiplatelet effects, but some patients have impaired thromboxane suppression - a phenomenon termed aspirin resistance. An explanation is that aspirin-independent thromboxane synthesis may occur through enhanced COX-2 activity, as would occur in an inflammatory condition such as lupus. However, little is known about the effects of low-dose aspirin in SLE. Thus, we propose to test the following hypothesis: 1) that aspirin insensitive thromboxane biosynthesis is increased in patients with lupus and is mediated by increased COX-2 activity.
Criteria: 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
Study is available at: Beth Israel Deaconess Medical Center
Boston, MA 02215
United States

Primary Contact:
Ingrid Avalos
Email: iavalos@bidmc.harvard.edu
Phone: 617-632-8998

Secondary Contact:
Charles M Stein
Email: michael.stein@vanderbilt.edu
Phone: 615 936 3420
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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