Clinical Trial: Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: University Hospital Ostrava

Current Primary Outcome:

  • Clinical manifestations of right ventricular failure and pulmonary hypertension and cardiovascular-related death [ Time Frame: 12 months ]
    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).
  • Pulmonary hypertension [ Time Frame: 12 months ]
    The primary outcome of the study is to follow pulmonary hypertension (measured in mmHg).
  • Cardiovascular-related deaths [ Time Frame: 12 months ]
    The primary outcome of the study is to follow the number of cardiovascular-related deaths within the time frame of 12 months.


Original Primary Outcome: Same as current

Current Secondary Outcome: Echocardiographic manifestations of right ventricular failure and pulmonary hypertension. [ Time Frame: 12 months ]

The secondary outcome measure of the study is to follow echocardiographic manifestations of right ventricular failure (TdiSm).


Original Secondary Outcome: Same as current

Information By: University Hospital Ostrava

Dates:
Date Received: April 28, 2014
Date Started: March 2011
Date Completion: December 2015
Last Updated: January 27, 2015
Last Verified: January 2015