Fondaparinux as Monotherapy for Deep Vein Thrombosis and/or Pulmonary Embolism (Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recurrent acute symptomatic DVT confirmed by venous ultrasound and/or CT scan
研究概览
简要总结
To determine whether fondaparinux as monotherapy without warfarin is effective and safe for long-term (90 days) treatment of DVT and/or PE, thus gaining new long-term experience and data using fondaparinux.
详细描述
Background and Significance:
Warfarin is usually prescribed to manage long-term anticoagulation of deep vein thrombosis (DVT) and pulmonary embolism (PE). However about 5% of patients are unable to tolerate warfarin or to be safely or effectively anticoagulated. Some of the reasons for discontinuing warfarin anticoagulation and switching patients to parenteral anticoagulation are as follows:
- Recurrent venous thromboembolism despite anticoagulation with warfarin
- Clinically important bleeding complications due to warfarin
- Inability to achieve target International Normalized Ratio (INR) on warfarin
- Nonbleeding side effects of warfarin, such as hair loss or rash.
These patients who cannot tolerate or respond adequately to warfarin are usually managed with "off-label" twice-daily enoxaparin injections as monotherapy. The approved duration of treatment of DVT and PE with fondaparinux is 5 to 9 days as a "bridge" to warfarin. Until now, no studies have investigated the use of fondaparinux for more than 26 days for the treatment of PE and more than 10 days for the treatment of DVT.
Treatment doses of twice-daily enoxaparin are only Food and Drug Administration (FDA) approved for 5 to 14 days for "bridging" for the treatment of acute DVT and/or PE patients to warfarin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Recurrent venous thromboembolism despite anticoagulation with warfarin(Or)
- •Clinically important bleeding complications due to warfarin(Or)
- •Inability to achieve the target INR on warfarin(Or)
- •Nonbleeding side effects of warfarin, such as hair loss, rash, purple toe syndrome(Or)
- •Patient with cancer on monotherapy with parenteral anticoagulation for DVT and/ or PE
- •Require at least 90 days of anticoagulation
- •Require anticoagulation for objectively confirmed DVT and/or PE
- •Age greater than 18 years
- •Written informed consent
排除标准
- •Patients with renal insufficiency, defined as creatinine > 1.5 mg/dl
- •Patients in whom anticoagulation with any agent is deemed unsafe due to bleeding risk.
- •Known hypersensitivity to fondaparinux
结局指标
主要结局
Recurrent acute symptomatic DVT confirmed by venous ultrasound and/or CT scan
时间窗: 90 Days
Recurrent acute symptomatic PE confirmed by chest CT scan
时间窗: 90 Days
Major hemorrhage defined as spinal, retroperitoneal or intracranial bleeding, drop in hemoglobin ≥2g/dl or transfusion ≥2U or surgical or medical intervention, death related to bleeding
时间窗: 90 Days
次要结局
- Comparison of Day Zero, 6 week, and Day 90 platelet counts, renal function, hematocrit and transaminase level(90 Days)