Aspirin Resistance in Systemic Lupus Erythematosus (SLE)

Phase 1

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: aspirin and meloxicam

• Registration Number: NCT00731302
• Lead Sponsor: Vanderbilt University

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aspirin and Meloxicam	aspirin and meloxicam	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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Vanderbilt University Medical School; 🇺🇸 Nashville, Tennessee, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States