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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02132689
Recruitment Status : Completed
First Posted : May 7, 2014
Last Update Posted : March 19, 2018
Sponsor:
Collaborators:
Municipal Hospital Ostrava Fifejdy
Silesian Hospital Opava
Information provided by (Responsible Party):
University Hospital Ostrava

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
Pulmonary Embolism 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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

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 Name: Actilyse

Drug: Heparine (Standard anticoagulation therapy)
Other Name: 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 Name: unfractionated/low-molecular weight heparine




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132689


Locations
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Czechia
Silesian Hospital Opava
Opava, Czechia, 746 01
University Hospital Ostrava
Ostrava-Poruba, Czechia, 708 52
Sponsors and Collaborators
University Hospital Ostrava
Municipal Hospital Ostrava Fifejdy
Silesian Hospital Opava
Investigators
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Principal Investigator: Radovan Stancik, MD Department of Cardiology, University Hospital Ostrava

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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT02132689    
Other Study ID Numbers: FNO-KVO-3
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Keywords provided by University Hospital Ostrava:
Moderate Risk Acute Pulmonary Embolism
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Anticoagulants
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action