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| Name | Class |
|---|---|
| Municipal Hospital Ostrava Fifejdy | UNKNOWN |
| Silesian Hospital Opava | UNKNOWN |
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Currently there is no clear guidance for the treatment of moderate risk of pulmonary embolism. The aim of the study is to compare two different therapeutic modalities - standard anticoagulation versus thrombolytic treatment followed by anticoagulation in standard regimen as stated in the pulmonary embolism guidelines.
Standard treatment of moderate risk pulmonary embolism constitutes of sole anticoagulation therapy. In case of troponin positivity and/or echocardiographic findings as i.e. thrombi in RV thrombolytic therapy should be considered. The aim of this trial is to compare the two treatment modalities in their ability to reduce/predict 12 month end-point: pulmonary hypertension, right ventricular failure, exercise capacity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actilyse | Active Comparator | Thrombolytic therapy: Patients treated with initial thrombolytic therapy (Actilyse) followed with anticoagulant therapy (unfractionated/low-molecular weight heparin). |
|
| UHF/LMWH | Active Comparator | Anticoagulation therapy: Patients treated with anticoagulation therapy only (unfractionated/low-molecular weight heparin). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actilyse (Thrombolytic therapy) | Drug |
|
| |
| Heparine (Standard anticoagulation therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical manifestations of right ventricular failure and pulmonary hypertension and cardiovascular-related death | The primary outcome of the study is to follow clinical manifestations of right ventricular failure (assessed according to the New York Heart Association /NYHA/ classification). | 12 months |
| Pulmonary hypertension | The primary outcome of the study is to follow pulmonary hypertension (measured in mmHg). | 12 months |
| Cardiovascular-related deaths | The primary outcome of the study is to follow the number of cardiovascular-related deaths within the time frame of 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiographic manifestations of right ventricular failure and pulmonary hypertension. | The secondary outcome measure of the study is to follow echocardiographic manifestations of right ventricular failure (TdiSm). | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Radovan Stancik, MD | Department of Cardiology, University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silesian Hospital Opava | Opava | 746 01 | Czechia | |||
| University Hospital Ostrava |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D015912 | Thrombolytic Therapy |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Drug |
|
|
| Ostrava-Poruba |
| 708 52 |
| Czechia |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |