Status:
COMPLETED
Aspirin Resistance in Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 patien...
Detailed Description
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 defini...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00731302
Start Date
April 1 2005
End Date
April 1 2017
Last Update
August 7 2017
Active Locations (2)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
Vanderbilt University Medical School
Nashville, Tennessee, United States, 37232