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

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Phase 4
Locations
Czechia
Study Type
Interventional
Intervention
Actilyse (Thrombolytic therapy)
Heparine (Standard anticoagulation therapy)
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Moderate Risk Acute Pulmonary Embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Silesian Hospital Opava
  • University Hospital Ostrava

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Actilyse

UHF/LMWH

Arm Description

Thrombolytic therapy: Patients treated with initial thrombolytic therapy (Actilyse) followed with anticoagulant therapy (unfractionated/low-molecular weight heparin).

Anticoagulation therapy: Patients treated with anticoagulation therapy only (unfractionated/low-molecular weight heparin).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
April 28, 2014
Last Updated
March 15, 2018
Sponsor
University Hospital Ostrava
Collaborators
Municipal Hospital Ostrava Fifejdy, Silesian Hospital Opava
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1. Study Identification

Unique Protocol Identification Number
NCT02132689
Brief Title
Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2011 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
Collaborators
Municipal Hospital Ostrava Fifejdy, Silesian Hospital Opava

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
Moderate Risk Acute Pulmonary Embolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Actilyse
Arm Type
Active Comparator
Arm Description
Thrombolytic therapy: Patients treated with initial thrombolytic therapy (Actilyse) followed with anticoagulant therapy (unfractionated/low-molecular weight heparin).
Arm Title
UHF/LMWH
Arm Type
Active Comparator
Arm Description
Anticoagulation therapy: Patients treated with anticoagulation therapy only (unfractionated/low-molecular weight heparin).
Intervention Type
Drug
Intervention Name(s)
Actilyse (Thrombolytic therapy)
Other Intervention Name(s)
Actilyse
Intervention Type
Drug
Intervention Name(s)
Heparine (Standard anticoagulation therapy)
Other Intervention Name(s)
unfractionated/low-molecular weight heparine
Primary Outcome Measure Information:
Title
Clinical manifestations of right ventricular failure and pulmonary hypertension and cardiovascular-related death
Description
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).
Time Frame
12 months
Title
Pulmonary hypertension
Description
The primary outcome of the study is to follow pulmonary hypertension (measured in mmHg).
Time Frame
12 months
Title
Cardiovascular-related deaths
Description
The primary outcome of the study is to follow the number of cardiovascular-related deaths within the time frame of 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Echocardiographic manifestations of right ventricular failure and pulmonary hypertension.
Description
The secondary outcome measure of the study is to follow echocardiographic manifestations of right ventricular failure (TdiSm).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radovan Stancik, MD
Organizational Affiliation
Department of Cardiology, University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
Silesian Hospital Opava
City
Opava
ZIP/Postal Code
746 01
Country
Czechia
Facility Name
University Hospital Ostrava
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia

12. IPD Sharing Statement

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Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism

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