A Prospective Randomized Controlled Trial of Hydroxychloroquine in the Primary Thrombosis Prophylaxis of aPL Positive But Thrombosis-free Patients.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Participants With an Acute Thrombosis Event
研究概览
简要总结
In this multi-center international study, our aim is to determine the effectiveness of HCQ for primary thrombosis prophylaxis in persistently aPL-positive but thrombosis-free patients without systemic autoimmune diseases.
详细描述
Randomized to receive HCQ or no treatment in addition to their standard regimen. 11 study visits and 10 phone visits over 5 years.
This study was terminated at 2 years due to low recruitment rate exacerbated by manufacturing shortage and price increase of hydroxychloroquine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent(at least 12 weeks apart)aPL-positivity within 12 months prior to the screening defined as:
- •aCL IgG/M (>40U,medium-to-high titer,and/or greater than the 99th percentile)and/or
- •aβ2GPI IgG/M(>40U, medium-to-high titer, and/or greater than the 99th percentile)and/or
- •Positive LA test based on the International Society of Thrombosis & Haematosis Recommendations
排除标准
- •History of thrombosis (arterial, venous, and/or biopsy proven microthrombosis
- •History of Transient Ischemic Attack Confirmed by a Neurologist
- •SLE Diagnosis based on the ACR Classification Criteria > 4/11
- •Other Systemic Autoimmune Diseases diagnosed based on ACR Classification Criteria
- •Current Hydroxychloroquine or another antimalarial treatment (-3 months)
- •Current warfarin treatment (-3 months)
- •Current heparin therapy( -3 months)
- •Current pregnancy
- •History of Hydroxychloroquine eye toxicity
- •History of Hydroxychloroquine allergy
- •Known glucose-6-phosphate dehydrogenase deficiency
研究组 & 干预措施
Hydroxychloroquine
Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing <60kg; and 400 mg daily (200 mg twice a day)for patients weighing >60kg.
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
Number of Participants With an Acute Thrombosis Event
时间窗: 2 years
To determine the efficacy of Hydroxychloroquine in the primary thrombosis prevention of persistently aPL-positive but thrombosis free patients with no other systemic autoimmune diseases over the five year study period.
次要结局
未报告次要终点