Pradaxa or Warfarin for Prevention of Recurrent VTE in Patients With Angiographically Confirmed Acute Massive Pulmonary Embolism undergoIng Endovascular Mechanical Fragmentation and Thrombolytic Therapy (Re-Spire)
2016年12月19日 更新者:Meshalkin Research Institute of Pathology of Circulation
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
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]
研究概览
地位
未知
研究类型
介入性
注册 (预期的)
200
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Andrey Karpenko, MD\PhD
- 邮箱:a_karpenko@meshalkin.ru
学习地点
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Novosibirsk、俄罗斯联邦、630055
- 招聘中
- Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:group of dabigatran
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All patients in this group continue to receive unfractionated heparin for 5-7 days, and then transferred to the drug Pradaxa dose of 150 mg 2 times a day.
Pradaxa administration continued until the end of the treatment period.
The treatment period starts on the day of randomization and lasts for 6 months.
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有源比较器:group of warfarin
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all patients continue to receive unfractionated heparin intravenously and at the same time (from the date of randomization) start warfarin, accompanied by regular measurement of the INR every day or every other day.
As soon as INR reaches the range of 2.0 to 3.0, the administration of the unfractionated heparin should be discontinued.
Further measurements of INR should be performed once a month during outpatient visits.
The patient continues to receive warfarin under the control of the INR till the end of the treatment period.
The treatment period starts on the day of randomization and lasts for 6 months.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
recurrent PE
大体时间:6 month
|
according to Echocardiogram, scintigraphy of the lungs
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6 month
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death
大体时间:6 month
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6 month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
hemorrhagic complications
大体时间:6 month
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according to the ISTH criteria
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6 month
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postembolic residual pulmonary hypertension
大体时间:6 month
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according to scintigraphy of the lungs
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6 month
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recurrent deep vein thrombosis
大体时间:3 month
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according to ultrasound of the deep veins
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3 month
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recurrent deep vein thrombosis
大体时间:6 month
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according to ultrasound of the deep veins
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6 month
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年10月1日
初级完成 (预期的)
2018年6月1日
研究完成 (预期的)
2018年6月1日
研究注册日期
首次提交
2016年11月22日
首先提交符合 QC 标准的
2016年11月30日
首次发布 (估计)
2016年12月1日
研究记录更新
最后更新发布 (估计)
2016年12月20日
上次提交的符合 QC 标准的更新
2016年12月19日
最后验证
2016年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.