Patients with acute symptomatic PE confirmed by contrast-enhanced chest CT with embolus located in at least one main or proximal lower lobe pulmonary artery and an end-diastolic diameter RV/LV ratio > 1.0 on echocardiography MedDRA version: 15.0 Level: PT Classification code 10037377 Term: Pulmonary embolism System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Actilyse
Product Name: Actilyse
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: ALTEPLASE
CAS Number: 105857236
Concentration unit: mg milligram(s)
C
Sponsors
EKOS Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with acute PE symptoms =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Age less than 18 years or greater than 80 years 2. Index acute PE symptom duration > 14 days 3. Insufficient echocardiographic image quality in the apical or subcostal four-chamber view that prohibits the measurement of the right and left ventricular end-diastolic dimensions 4. Known significant bleeding risk 5. Administration of thrombolytic agents within the previous 4 days 6. Active bleeding 7. Known bleeding diathesis 8. Known coagulation disorder platelet count 90 mm Hg. 16. Severe hypertension on repeated readings (systolic > 180 mmHg or diastolic > 105 mmHg). 17. Pregnant, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested ). 18. Participating in any other investigational drug or device study. 19. Life expectancy 10 mm) right atrial or right ventricular thrombus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients with documented PE and right heart dysfunction, determine if treatment with ultrasound accelerated thrombolysis will significantly improve right heart function at 24 hours compared to patients receiving anticoagulation alone. ;Secondary Objective: 1) Determine PE symptoms at 24 hours and at 90 days, 2) Evaluate right heart function by echocardiography at 90 days, 3) Determine exercise capacity by 6-minute walk test at 90 days;Primary end point(s): 7 EFFICACY OUTCOMES 7.1 Primary Efficacy Outcome Change in the end-diastolic RV/LV ratio from baseline to 24 hours by echocardiography. ;Timepoint(s) of evaluation of this end point: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 7.2 Secondary Efficacy Outcomes 1) PE symptoms at 24 hours and at 90 days, 2) Right heart function by echocardiography at 90 days, 3) Exercise capacity by 6-minute walk test at 90 days. 8 SAFETY OUTCOMES • Major bleeding at 30 days (see definitions below). • Intracranial bleeding at 30 days. • Haemodynamic collapse at discharge • need for cardiopulmonary resuscitation; or • systolic blood pressure 90 mm Hg (including dopamine at the rate of > 5 micrograms / kg per minute) • Recurrent symptomatic pulmonary embolism at 90 days. • Mortality at 90 days. ;Timepoint(s) of evaluation of this end point: 24 hours and 90 days | — |
Countries
Germany, Switzerland
Contacts
Public ContactHans-Joachim Lau
Dr. Hans-Joachim Lau - Consultant
Outcome results
None listed