Systemic Lupus Erythematosus
Conditions
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 patients with lupus and controls and see if aspirin insensitive thromboxane production is inhibited by meloxicam.
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.
Interventions
DRUGaspirin and meloxicam
aspirin 81 mg daily then aspirin 81 mg plus meloxicam 7.5 mg daily
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Vanderbilt University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| thromboxane | after aspirin and after aspirin plus meloxicam | a hormone of the prostacyclin type released from blood platelets. It induces platelet aggregation and arterial constriction. |
Countries
United States
Outcome results
None listed