Post-marketing Study of Monteplase ("Cleactor") in Patients With Acute Pulmonary Embolism

Pulmonary Embolism Clinical Trial

Official title:

Pharmacokinetic/Pharmacodynamic Study of Monteplase ("Cleactor") in Acute Pulmonary Embolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00442234
• Other study ID #: E6010-J081-591
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2007
• Est. completion date: April 1, 2008

Study information

• Verified date: January 2010
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 1, 2008
• Est. primary completion date: April 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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:

1. Confirmed to have thrombi, emboli, or disorders in pulmonary circulation detected by pulmonary angiography or computed tomography.

2. 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

3. Mean pulmonary arterial pressure (PAP) is 20 mmHg or above

4. PaO2 is 65 mmHg or below (confirmed by blood gas analysis)

Exclusion Criteria:

1. Patients with concurrent hemorrhage (e.g., gastrointestinal bleeding, urinary tract bleeding, retroperitoneal bleeding, intracranial bleeding, or hemoptysis).

2. Patients who underwent intracranial or spinal operation or injury within 2 months prior to study treatment.

3. Patients with intracranial tumor, arteriovenous malformation, or aneurysm

4. Patients with hemorrhagic diathesis (e.g., vascular purpura, thrombocytopenia, hemophilia)

5. Patients with hypertension of systolic blood pressure >=180 mmHg or diastolic pressure >= 110 mmHg.

6. Patients with a history of cerebrovascular disorder (e.g., cerebral infarction, intracerebral hemorrhage).

7. Patients with severe hepatic disorder (e.g., cirrhosis, severe hepatitis) or severe renal disorder (e.g., renal failure).

8. Patients received thrombolytic drug (t-PA or urokinase) within 7 days prior to study treatment.

9. Patients with pulmonary cardiac arrest (CPA).

10. Patients with a history of hypersensitivity to monteplase or protein preparations.

11. 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.

12. Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Drug:
• Monteplase

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eisai Inc.	Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monteplase antigen levels in plasma; Monteplase activity in plasma; parameters of coagulating and fibrinolytic system (Plasminogen activity, a2-PI, PIC, fibrinogen, D-dimer).
Secondary	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.