Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism in Context of Pulmonary Hypertension, Right Heart Failure and Patient Functional Ability
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Pulmonary hypertension
Study Overview
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 Description
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Actilyse
Thrombolytic therapy: Patients treated with initial thrombolytic therapy (Actilyse) followed with anticoagulant therapy (unfractionated/low-molecular weight heparin).
Intervention: Actilyse (Thrombolytic therapy) (Drug)
Actilyse
Thrombolytic therapy: Patients treated with initial thrombolytic therapy (Actilyse) followed with anticoagulant therapy (unfractionated/low-molecular weight heparin).
Intervention: Heparine (Standard anticoagulation therapy) (Drug)
UHF/LMWH
Anticoagulation therapy: Patients treated with anticoagulation therapy only (unfractionated/low-molecular weight heparin).
Intervention: Heparine (Standard anticoagulation therapy) (Drug)
Outcomes
Primary Outcomes
Pulmonary hypertension
Time Frame: 12 months
The primary outcome of the study is to follow pulmonary hypertension (measured in mmHg).
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).
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.
Secondary Outcomes
- Echocardiographic manifestations of right ventricular failure and pulmonary hypertension.(12 months)