Aspirin Resistance in Systemic Lupus Erythematosus (SLE)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Systemic Lupus Erythematosus |
Drug: aspirin, aspirin plus meloxicam |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label |
- thromboxane [ Time Frame: after aspirin and after aspirin plus meloxicam ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: I
81 mg aspirin followed by meloxicam 7.5 mg daily plus aspirin 81 mg daily
|
Drug: aspirin, aspirin plus meloxicam
aspirin 81 mg daily then aspirin 81 mg plus meloxicam 7.5 mg daily
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Tennessee | |
| Vanderbilt University Medical School | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | C M Stein, M.D. | Vanderbilt University |
More Information
No publications provided
| Responsible Party: | C. Michael Stein, Dan May Professor of Medicine, Professor of Pharmacology, Associate Director of the Division of Clinical Pharmacology, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00731302 History of Changes |
| Other Study ID Numbers: | HL65082 |
| Study First Received: | August 5, 2008 |
| Last Updated: | December 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Aspirin Meloxicam Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013