Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital Ostrava (Other)
Overall Status
Completed
CT.gov ID
NCT02132689
Collaborator
Municipal Hospital Ostrava Fifejdy (Other), Silesian Hospital Opava (Other)
100
Enrollment
2
Locations
2
Arms
57
Actual Duration (Months)
50
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Actilyse (Thrombolytic therapy)
  • Drug: Heparine (Standard anticoagulation therapy)
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism in Context of Pulmonary Hypertension, Right Heart Failure and Patient Functional Ability
Actual Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. Pulmonary hypertension [12 months]

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

    3. 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

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Silesian Hospital Opava Opava Czechia 746 01
    2 University Hospital Ostrava Ostrava-Poruba Czechia 708 52

    Sponsors and Collaborators

    • University Hospital Ostrava
    • Municipal Hospital Ostrava Fifejdy
    • Silesian Hospital Opava

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Ostrava
    ClinicalTrials.gov Identifier:
    NCT02132689
    Other Study ID Numbers:
    • FNO-KVO-3
    First Posted:
    May 7, 2014
    Last Update Posted:
    Mar 19, 2018
    Last Verified:
    Mar 1, 2018
    Keywords provided by University Hospital Ostrava
    Moderate Risk Acute Pulmonary Embolism
    Additional relevant MeSH terms:
    Pulmonary Embolism
    Embolism
    Tissue Plasminogen Activator
    Fibrinolytic Agents
    Heparin
    Calcium heparin

    Study Results

    No Results Posted as of Mar 19, 2018