Post-marketing Study of Monteplase ("Cleactor") in Patients With Acute Pulmonary Embolism
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ClinicalTrials.gov Identifier: NCT00442234 |
Recruitment Status :
Completed
First Posted : March 1, 2007
Last Update Posted : October 18, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Embolism | Drug: Monteplase | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pharmacokinetic/Pharmacodynamic Study of Monteplase ("Cleactor") in Acute Pulmonary Embolism |
Actual Study Start Date : | May 1, 2007 |
Actual Primary Completion Date : | April 1, 2008 |
Actual Study Completion Date : | April 1, 2008 |
- Monteplase antigen levels in plasma; Monteplase activity in plasma; parameters of coagulating and fibrinolytic system (Plasminogen activity, a2-PI, PIC, fibrinogen, D-dimer).
- 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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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442234
Japan | |
Yokohama, Kanagawa, Japan, 245-8575 | |
Bunkyo-ku, Tokyo, Japan, 113-8603 |
Study Director: | Takashi Musha | Department Marketed Product Research, Clinical Research Center |
Responsible Party: | Eisai Inc. |
ClinicalTrials.gov Identifier: | NCT00442234 |
Other Study ID Numbers: |
E6010-J081-591 |
First Posted: | March 1, 2007 Key Record Dates |
Last Update Posted: | October 18, 2018 |
Last Verified: | January 2010 |
Acute pulmonary embolism |
accompanying hemodynamic instability |
Fibrinolytic Agents Pulmonary Embolism Embolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Lung Diseases Respiratory Tract Diseases Monteplase Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |