Pulmonary EmbolismPhase 4CONTACT-SPENCT02132689
Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism
A Phase 4 study testing Actilyse (Thrombolytic therapy) and Heparine (Standard anticoagulation therapy) in people with Pulmonary Embolism, run by University Hospital Ostrava at 2 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Actilyse (Thrombolytic therapy) and Heparine (Standard anticoagulation therapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCzechia
- Study dates
- Mar 2011to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate risk pulmonary embolism as defined by the European Society of Cardiology /ESC/ guidelines
- signed informed consent
Who cannot join
- patient not willing to sigh informed consent
- absolute contraindication of thrombolysis
- inability to obtain meaningfull echocardiographic images¨
- pulmonary arterial hypertension
- known right ventricular failure
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Silesian Hospital Opava
Opava, 746 01
University Hospital Ostrava
Ostrava-Poruba, 708 52
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Embolism
- Being tested
- Actilyse (Thrombolytic therapy), Heparine (Standard anticoagulation therapy)
- Keywords
- Moderate Risk Acute Pulmonary Embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actilyse (Thrombolytic therapy)Drug
Also called Actilyse
Heparine (Standard anticoagulation therapy)Drug
Also called unfractionated/low-molecular weight heparine
| Study group | Role | What they receive |
|---|---|---|
| Actilyse | Active comparator | Thrombolytic therapy: Patients treated with initial thrombolytic therapy (Actilyse) followed with anticoagulant therapy (unfractionated/low-molecular weight heparin). Receives: Drug: Actilyse (Thrombolytic therapy); Drug: Heparine (Standard anticoagulation therapy) |
| UHF/LMWH | Active comparator | Anticoagulation therapy: Patients treated with anticoagulation therapy only (unfractionated/low-molecular weight heparin). Receives: Drug: Heparine (Standard anticoagulation therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Pulmonary hypertension
The primary outcome of the study is to follow pulmonary hypertension (measured in mmHg).
Measured: 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.
Measured: 12 months
Secondary outcomes (1)
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startMar 2011
- Primary completionMay 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- Municipal Hospital Ostrava Fifejdy, Silesian Hospital Opava
- Responsible party
- Sponsor
- Investigators
- Radovan Stancik, MD, Principal investigator, Department of Cardiology, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132689
- Sponsor's protocol ID
- FNO-KVO-3
- Acronym
- CONTACT-SPE
- Status last verified
- Mar 2018
- First submitted
- 28 Apr 2014
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism in Context of Pulmonary Hypertension, Right Heart Failure and Patient Functional Ability
- ClinicalTrials.gov ID
- NCT02132689
- Acronym / sponsor ID
- CONTACT-SPE / FNO-KVO-3
- Conditions
- Pulmonary Embolism
- Keywords
- Moderate Risk Acute Pulmonary Embolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- Municipal Hospital Ostrava Fifejdy, Silesian Hospital Opava
- Study start
- Mar 2011 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actilyse | Active comparator | Drug: Actilyse (Thrombolytic therapy), Drug: Heparine (Standard anticoagulation therapy)Thrombolytic therapy: Patients treated with initial thrombolytic therapy (Actilyse) followed with anticoagulant therapy (unfractionated/low-molecular weight heparin). |
| UHF/LMWH | Active comparator | Drug: Heparine (Standard anticoagulation therapy)Anticoagulation therapy: Patients treated with anticoagulation therapy only (unfractionated/low-molecular weight heparin). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- moderate risk pulmonary embolism as defined by the European Society of Cardiology /ESC/ guidelines
- signed informed consent
Key exclusion criteria (5 listed)
- patient not willing to sigh informed consent
- absolute contraindication of thrombolysis
- inability to obtain meaningfull echocardiographic images¨
- pulmonary arterial hypertension
- known right ventricular failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actilyse (Thrombolytic therapy)Also: Actilyse | Drug | Actilyse |
| Heparine (Standard anticoagulation therapy)Also: unfractionated/low-molecular weight heparine | Drug | Actilyse, UHF/LMWH |
Primary outcome
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).
Pulmonary hypertension
Time frame: 12 months
The primary outcome of the study is to follow pulmonary hypertension (measured in mmHg).
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.
1 secondary outcome
Echocardiographic manifestations of right ventricular failure and pulmonary hypertension.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radovan Stancik, MD principal investigator
Department of Cardiology, University Hospital Ostrava
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Actilyse (Thrombolytic therapy) and Heparine (Standard anticoagulation therapy) in people with Pulmonary Embolism, run by University Hospital Ostrava at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical manifestations of right ventricular failure and pulmonary hypertension and cardiovascular-related death (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.