Vascular Damage in Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- thromboxane
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: aspirin and meloxicam (Drug)
结局指标
主要结局
thromboxane
时间窗: after aspirin and after aspirin plus meloxicam
a hormone of the prostacyclin type released from blood platelets. It induces platelet aggregation and arterial constriction.
次要结局
未报告次要终点
研究者
C. Michael Stein
Dan May Professor of Medicine, Professor of Pharmacology, Associate Director of the Division of Clinical Pharmacology
Vanderbilt University