NCT02979561Unknown4 期
A Prospective Randomised Controlled Study to Evaluate Outcomes of the Treatment With Pradaxa or Warfarin for Prevention of Recurrent VTE in Patients With Angiographically Confirmed Acute Massive Pulmonary Embolism Undergoing Endovascular Mechanical Fragmentation and Thrombolytic Therapy
Meshalkin Research Institute of Pathology of Circulation1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- death
研究概览
简要总结
A prospective randomised controlled study to evaluate outcomes of the treatment with pradaxa or warfarin for prevention of recurrent DVT in patients with angiographically confirmed acute massive pulmonary embolism undergoIng endovascular mechanical fragmentation and thrombolytic therapy. [RE-SPIRE study]
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged > 18 years
- •Angiographically confirmed acute massive pulmonary embolism with involvement of Central pulmonary arteries.
- •endovascular mechanical thrombus fragmentation + thrombolytic therapy (using recombinant tissue activator of plasminogen), performed for treatment of the above-mentioned pulmonary embolism in less than 48 hours before randomization. The patient should be randomized no earlier than 24 hours after procedures endovascular mechanical thrombus fragmentation + thrombolytic therapy
- •Written informed consent signed by patient.
排除标准
- •Signs of hemodynamic instability (i.e. systolic blood pressure <100 mm Hg.St. or episode of systolic blood pressure fall for ≥40 mm Hg. / or heart rate > 110 lasting more than 15 min) or need for ventilatory support within 12 hours prior to randomisation.
- •The indication for oral anticoagulation, associated with others disease.
- •malignant neoplasm of any location
- •Contraindications to warfarin or pradaxa according to Russian Instructions for medical use of these drugs
- •Indications for concomitant treatment with antiplatelet agents
- •Any stroke within 6 months before randomization
- •Intracranial hemorrhage in anamnesis
- •Active bleeding, bleeding diathesis.
- •Clinically significant bleeding within the last 30 days.
- •Trauma or extensive surgery within 1 month before randomization or surgery planned in the next 6 months after randomization.
- •Intracranial pathology: tumor, arteriovenous fistula or aneurysm.
- •Gastrointestinal bleeding in the previous 3 months.
- •Gastric ulcer or duodenal ulcer with clinical manifestations or endoscopically identified acute ulcer without signs of scarring during previous 30 days.
- •Uncontrolled hypertension (systolic blood pressure> 180 mm Hg. and / or diastolic blood pressure> 100 mm.hg in patients receiving antihypertensive drugs).
- •Pregnancy, lactation.
- •Life expectancy <6 months.
- •Clinically significant liver disease.
- •Creatinine clearance (estimated by Cockcroft-Gault) <30 ml / min.
- •hemoglobin level <90 g/l), thrombocytopenia <100x10^9 / L.
- •Patients who, in the opinion of the researcher, are not suitable for inclusion in the study, for example, due to the low likelihood of doctor's recommendations following.
- •Long-term use of NSAIDs
- •Current participation in another clinical study.
- •Allergic to contrast substance or radioisotope drugs used in procedures to assess endpoints of the study, which according to researchers, may be a contraindication to the implementation of these research methods.
研究组 & 干预措施
group of dabigatran
Experimental
干预措施: Dabigatran Etexilate (Drug)
group of warfarin
Active Comparator
干预措施: Warfarin (Drug)
结局指标
主要结局
death
时间窗: 6 month
recurrent PE
时间窗: 6 month
according to Echocardiogram, scintigraphy of the lungs
次要结局
- recurrent deep vein thrombosis(6 month)
- hemorrhagic complications(6 month)
- postembolic residual pulmonary hypertension(6 month)
研究者
研究点 (1)
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