This trial is active, not recruiting.

Condition systemic lupus erythematosus
Treatment aspirin and meloxicam
Phase phase 1
Sponsor Vanderbilt University
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date April 2005
End date December 2016
Trial size 120 participants
Trial identifier NCT00731302, HL65082, R01HL065082


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacodynamics study
Intervention model single group assignment
Masking open label
Arm: Aspirin and Meloxicam Each participant will receive 81 mg aspirin per day for 7 days, followed by meloxicam 7.5 mg daily plus aspirin 81 mg daily for 5 days
aspirin and meloxicam generic, not applicable
aspirin 81 mg daily then aspirin 81 mg plus meloxicam 7.5 mg daily

Primary Outcomes

time frame: after aspirin and after aspirin plus meloxicam

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Vascular Damage in Systemic Lupus Erythematosus (SLE)
Principal investigator C M Stein, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Vanderbilt University.