Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism

Phase 4

Completed

• Conditions: Pulmonary Embolism
• Interventions: Drug: Actilyse (Thrombolytic therapy); Drug: Heparine (Standard anticoagulation therapy)

• Registration Number: NCT02132689
• Lead Sponsor: University Hospital Ostrava

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-07
• Primary Completion: 2015-05
• Study Completion: 2015-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-15
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Actilyse	Actilyse (Thrombolytic therapy)	Thrombolytic therapy: Patients treated with initial thrombolytic therapy (Actilyse) followed with anticoagulant therapy (unfractionated/low-molecular weight heparin).
Actilyse	Heparine (Standard anticoagulation therapy)	Thrombolytic therapy: Patients treated with initial thrombolytic therapy (Actilyse) followed with anticoagulant therapy (unfractionated/low-molecular weight heparin).
UHF/LMWH	Heparine (Standard anticoagulation therapy)	Anticoagulation therapy: Patients treated with anticoagulation therapy only (unfractionated/low-molecular weight heparin).

Primary Outcome Measures

Name	Time	Method
Clinical manifestations of right ventricular failure and pulmonary hypertension and cardiovascular-related death	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	12 months	The primary outcome of the study is to follow pulmonary hypertension (measured in mmHg).
Cardiovascular-related deaths	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 Outcome Measures

Name	Time	Method
Echocardiographic manifestations of right ventricular failure and pulmonary hypertension.	12 months	The secondary outcome measure of the study is to follow echocardiographic manifestations of right ventricular failure (TdiSm).

Trial Locations

Locations (2)

Silesian Hospital Opava; 🇨🇿 Opava, Czechia

University Hospital Ostrava; 🇨🇿 Ostrava-Poruba, Czechia