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Completed

NCT Number: NCT02132689

Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism

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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Silesian Hospital Opava, Opava, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Actilyse (Thrombolytic therapy)

Drug

Other names: Actilyse

Heparine (Standard anticoagulation therapy)

Drug

Other names: unfractionated/low-molecular weight heparine

Primary outcomes

  1. 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).

  2. Pulmonary hypertension

    Time frame: 12 months

    The primary outcome of the study is to follow pulmonary hypertension (measured in mmHg).

  3. 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

  1. 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).

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • Municipal Hospital Ostrava Fifejdy
  • Silesian Hospital Opava

Registry information

Official study title

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

Acronym: CONTACT-SPE

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 7, 2014
Registry last updated
Mar 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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