Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients
研究概览
简要总结
The purpose of this study is to determine whether a drug named Fluvastatin is beneficial and safe in reducing the risk of cardiovascular disease and blood clots in patients with antiphospholipid antibodies or Antiphospholipid Syndrome (APS).
详细描述
The primary objective of the study is to determine the effects of fluvastatin on pro-thrombotic and pro-inflammatory markers in aPL-positive lupus and non-lupus patients (primary endpoint) and to determine the safety of fluvastatin in aPL-positive lupus and non-lupus patients (secondary endpoint).
All eligible patients will sign an IRB-approved consent form during the screening visit and give blood for baseline laboratory tests. Within a week of the screening visit, all patients will be started on Fluvastatin 40 mg daily for three months. At three months patients will be instructed to stop the study medication and they will be followed for another three months. Thus, the total duration of the study is six months: first three months is interventional and the last three months is observational.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistently antiphospholipid-antibody positive patients (positive lupus anticoagulant test, anticardiolipin antibody ≥ 40 GPL /MPL, and/or anti- β2-glycoprotein I antibody > 20 SGU/SMU) with or without systemic lupus erythematosus
排除标准
- •Younger than 18 year-old
- •Planning to get pregnant within the next 6 months
- •Taking other cholesterol lowering agents
- •Taking other immunosuppressive medications (such as methotrexate, azathioprine, cellcept, enbrel, remicade, or rituximab)(Hydroxychloroquine [Plaquenil] during the study period is allowed).
- •Treatment with biologic agents including anti-TNF medications and Rituximab
- •Treatment with erythromycin, itraconazole, or clarithromycin
- •Taking prednisone higher than 10 mg daily
- •Taking non-steroidal anti-inflammatory drug (such as Motrin, Advil, etc) regularly
- •Have a muscle or liver disease
- •Have chronic renal disease requiring dialysis
- •Have hepatitis C and/or HIV infection
- •Have active infections requiring antibiotics
- •Have the diagnosis of a systemic autoimmune disease (such as rheumatoid arthritis or systemic sclerosis) other than lupus
- •Have diagnosis of another chronic condition requiring corticosteroid treatment more than 10mg daily
- •History of an allergic reaction to cholesterol lowering agents
研究组 & 干预措施
Fluvastatin
All patients will take Fluvastatin 40 mg daily for 3 months.
干预措施: Fluvastatin (Drug)
结局指标
主要结局
Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients
时间窗: 3 months
Biomarkers sICAM-1 (ng/mL), sVCAM-1 (ng/mL), sE-sel (ng/mL)
次要结局
未报告次要终点