Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism (CONTACT-SPE)

March 15, 2018 updated by: University Hospital Ostrava

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Opava, Czechia, 746 01
        • Silesian Hospital Opava
      • Ostrava-Poruba, Czechia, 708 52
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Actilyse
Thrombolytic therapy: Patients treated with initial thrombolytic therapy (Actilyse) followed with anticoagulant therapy (unfractionated/low-molecular weight heparin).
Drug: Actilyse (Thrombolytic therapy)
Other Names:
  • Actilyse
Drug: Heparine (Standard anticoagulation therapy)
Other Names:
  • unfractionated/low-molecular weight heparine
Active Comparator: UHF/LMWH
Anticoagulation therapy: Patients treated with anticoagulation therapy only (unfractionated/low-molecular weight heparin).
Drug: Heparine (Standard anticoagulation therapy)
Other Names:
  • unfractionated/low-molecular weight heparine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months
Pulmonary hypertension
Time Frame: 12 months
The primary outcome of the study is to follow pulmonary hypertension (measured in mmHg).
12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Collaborators

Municipal Hospital Ostrava Fifejdy
Silesian Hospital Opava

Investigators

  • Principal Investigator: Radovan Stancik, MD, Department of Cardiology, University Hospital Ostrava

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2011

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 15, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNO-KVO-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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