Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism in Context of Pulmonary Hypertension, Right Heart Failure and Patient Functional Ability

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Drug: Actilyse (Thrombolytic therapy)
* Drug: Heparine (Standard anticoagulation therapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate risk pulmonary embolism as defined by the European Society of Cardiology /ESC/ guidelines signed informed consent Exclusion Criteria: patient not willing to sigh informed consent absolute contraindication of thrombolysis inability to obtain meaningfull echocardiographic images¨ pulmonary arterial hypertension known right ventricular failure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Actilyse<br>Thrombolytic therapy: Patients treated with initial thrombolytic therapy (Actilyse) followed with anticoagulant therapy (unfractionated/low-molecular weight heparin). | Drug: Actilyse (Thrombolytic therapy)<br> <br> * Other names: Actilyse;Drug: Heparine (Standard anticoagulation therapy)<br> <br> * Other names: unfractionated/low-molecular weight heparine;|
| Active Comparator: UHF/LMWH<br>Anticoagulation therapy: Patients treated with anticoagulation therapy only (unfractionated/low-molecular weight heparin). | Drug: Heparine (Standard anticoagulation therapy)<br> <br> * Other names: unfractionated/low-molecular weight heparine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate Risk Acute Pulmonary Embolism