Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism
CONTACT-SPE
1 other identifier
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2011
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 28, 2014
CompletedFirst Posted
Study publicly available on registry
May 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 19, 2018
March 1, 2018
4.2 years
April 28, 2014
March 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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).
12 months
Pulmonary hypertension
The primary outcome of the study is to follow pulmonary hypertension (measured in mmHg).
12 months
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.
12 months
Secondary Outcomes (1)
Echocardiographic manifestations of right ventricular failure and pulmonary hypertension.
12 months
Study Arms (2)
Actilyse
ACTIVE COMPARATORThrombolytic therapy: Patients treated with initial thrombolytic therapy (Actilyse) followed with anticoagulant therapy (unfractionated/low-molecular weight heparin).
UHF/LMWH
ACTIVE COMPARATORAnticoagulation therapy: Patients treated with anticoagulation therapy only (unfractionated/low-molecular weight heparin).
Interventions
Eligibility Criteria
You may qualify if:
- moderate risk pulmonary embolism as defined by the European Society of Cardiology /ESC/ guidelines
- signed informed consent
You may not qualify if:
- patient not willing to sigh informed consent
- absolute contraindication of thrombolysis
- inability to obtain meaningfull echocardiographic images¨
- pulmonary arterial hypertension
- known right ventricular failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Ostravalead
- Municipal Hospital Ostrava Fifejdycollaborator
- Silesian Hospital Opavacollaborator
Study Sites (2)
Silesian Hospital Opava
Opava, 746 01, Czechia
University Hospital Ostrava
Ostrava-Poruba, 708 52, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Radovan Stancik, MD
Department of Cardiology, University Hospital Ostrava
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2014
First Posted
May 7, 2014
Study Start
March 1, 2011
Primary Completion
May 1, 2015
Study Completion
December 1, 2015
Last Updated
March 19, 2018
Record last verified: 2018-03