Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— CONTACT-SPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132689
• Other study ID #: FNO-KVO-3
• Status: Completed
• Phase: Phase 4
• First received: April 28, 2014
• Last updated: March 15, 2018
• Start date: March 2011
• Est. completion date: December 2015

Study information

• Verified date: March 2018
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Drug:
• Actilyse (Thrombolytic therapy)

• Heparine (Standard anticoagulation therapy)

Locations

Country	Name	City	State
Czechia	Silesian Hospital Opava	Opava
Czechia	University Hospital Ostrava	Ostrava-Poruba

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Ostrava	Municipal Hospital Ostrava Fifejdy, Silesian Hospital Opava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pulmonary hypertension	The primary outcome of the study is to follow pulmonary hypertension (measured in mmHg).	12 months
Primary	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	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