Aspirin Resistance in Systemic Lupus Erythematosus (SLE)
Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Systemic Lupus Erythematosus
Intervention: aspirin, aspirin plus meloxicam (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s):
C M Stein, M.D., Principal Investigator, Affiliation: Vanderbilt University
Overall contact:
Charles M Stein, Phone: 615 936 3420, Email: michael.stein@vanderbilt.edu
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 patients with lupus and controls and see if aspirin insensitive thromboxane
production is inhibited by meloxicam.
Clinical Details
Study design: Other, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Primary outcome: thromboxane
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Charles M Stein, Phone: 615 936 3420, Email: michael.stein@vanderbilt.edu
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Ingrid Avalos, Phone: 617-632-8998, Email: iavalos@bidmc.harvard.edu
Vanderbilt University Medical School, Nashville, Tennessee 37232, United States; Recruiting
Charles M Stein, Phone: 615-936-3420, Email: michael.stein@vanderbilt.edu
Charles M Stein, Principal Investigator
Additional Information
Starting date: April 2005
Ending date: April 2010
Last updated: February 18, 2009
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