Post-marketing Study of Monteplase ("Cleactor") in Patients With Acute Pulmonary Embolism
Pharmacokinetic/Pharmacodynamic Study of Monteplase ("Cleactor") in Acute Pulmonary Embolism
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Kanagawa
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Yokohama、Kanagawa、日本、245-8575
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Tokyo
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Bunkyo-ku、Tokyo、日本、113-8603
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
1) Patients who consent for study participation and submit written informed consent with free will by patient or legally authorized representative.
2) Patients aged between 20 years or above and under 75 years old at the time of obtaining informed consent.
3) Patients with acute pulmonary embolism within 5 days after the onset.
4) Patients with acute pulmonary embolism with hemodynamic instability and fulfill all of the following 4 items:
- Confirmed to have thrombi, emboli, or disorders in pulmonary circulation detected by pulmonary angiography or computed tomography.
Confirmed to have any of the following right ventricular overloads by echocardiography:
i) Dilation of right ventricular cavity or hypokinesis in ventricular wall
ii) Floating thrombi in pulmonary artery and right heart
iii) Paradoxical motion in the interventricular septum
iv) Disparity of tricuspid regurgitation pressure
v) Enlargement of pulmonary artery
- Mean pulmonary arterial pressure (PAP) is 20 mmHg or above
- PaO2 is 65 mmHg or below (confirmed by blood gas analysis)
Exclusion Criteria:
- Patients with concurrent hemorrhage (e.g., gastrointestinal bleeding, urinary tract bleeding, retroperitoneal bleeding, intracranial bleeding, or hemoptysis).
- Patients who underwent intracranial or spinal operation or injury within 2 months prior to study treatment.
- Patients with intracranial tumor, arteriovenous malformation, or aneurysm
- Patients with hemorrhagic diathesis (e.g., vascular purpura, thrombocytopenia, hemophilia)
- Patients with hypertension of systolic blood pressure >=180 mmHg or diastolic pressure >= 110 mmHg.
- Patients with a history of cerebrovascular disorder (e.g., cerebral infarction, intracerebral hemorrhage).
- Patients with severe hepatic disorder (e.g., cirrhosis, severe hepatitis) or severe renal disorder (e.g., renal failure).
- Patients received thrombolytic drug (t-PA or urokinase) within 7 days prior to study treatment.
- Patients with pulmonary cardiac arrest (CPA).
- Patients with a history of hypersensitivity to monteplase or protein preparations.
- Pregnant women, women suspected of being pregnant, women who desire to become pregnant during a period between obtaining informed consent to the final observation, or lactating women.
- Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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Monteplase antigen levels in plasma; Monteplase activity in plasma; parameters of coagulating and fibrinolytic system (Plasminogen activity, a2-PI, PIC, fibrinogen, D-dimer).
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次要结果测量
结果测量 |
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Symptoms and signs of acute pulmonary embolism; pulmonary thrombosis; echocardiography; pulmonary arterial pressure; blood gas; vital signs; laboratory tests (e.g., hematology and blood chemistry); adverse events; concomitant therapies; dosing regimen.
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合作者和调查者
赞助
合作者
调查人员
- 研究主任:Takashi Musha、Department Marketed Product Research, Clinical Research Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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