Status:
COMPLETED
Post-marketing Study of Monteplase ("Cleactor") in Patients With Acute Pulmonary Embolism
Lead Sponsor:
Eisai Inc.
Collaborating Sponsors:
Eisai Co., Ltd.
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
20-75 years
Phase:
PHASE4
Brief Summary
To investigate PK and coagulating and fibrinolytic parameter profiles (PD) at the approved dose (13,750 - 27,500 IU/kg) in patients with acute pulmonary embolism accompanying hemodynamic instability.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00442234
Start Date
May 1 2007
End Date
April 1 2008
Last Update
October 18 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Yokohama, Kanagawa, Japan, 245-8575
2
Bunkyo-ku, Tokyo, Japan, 113-8603