Trial | NCT02132689  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    heparin alteplase ...

  • Study Participants

    100
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.
Study Started
Mar 31
2011
Primary Completion
May 31
2015
Study Completion
Dec 31
2015
Last Update
Mar 19
2018

Drug Actilyse (Thrombolytic therapy)

  • Other names: Actilyse

Drug Heparine (Standard anticoagulation therapy)

  • Other names: unfractionated/low-molecular weight heparine

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).

Criteria 

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
No Results Posted