Venous Thromboembolic DiseaseNCT03887806
Cost Effectiveness Analysis of an Ancillary Study of the REMOTEV Study
An observational study of Venous Thromboembolic Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The implications of the medico-economic impact are essential in the choice of first-line therapists. The economic impact is an important criterion to recommend the privileged use of Direct Oral Anticoagulants (AOD) in first intention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolic Disease
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2019to 20 Mar 2020
- Phase
- Observational
- 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
Study population: Patient with a diagnosis of MTEV: pulmonary embolism or deep vein thrombosis diagnosed by the diagnostic reference methods according to the recommendations
Who may be able to join
- Major patient whose age is ≥18 years
- Patient with a diagnosis of MTEV: pulmonary embolism or deep vein thrombosis diagnosed by the diagnostic reference methods according to the recommendations
- Major patient included in the REMOTEV registry
- Patient having accepted that his data recorded in the REMOTEV register be re-used for research and publication purposes
- Criteria of non-inclusion
- Refusal to participate in the REMOTEV register
Show all 9Show fewer
- Patient who refused to have his data reused for research and publication purposes
- Pregnant woman
- Subjects under safeguard of justice Subject under guardianship or curatorship
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Des Maladies Vasculaires - Hta - Nhc
Strasbourg, 67091
Dominique STEPHAN, MD, PhD, 33.3.69.55.09.52, Dominique.Stephan@chru-strasbourg.fr
Elena-Mihaela CORDEANU, MD, 33 3 69 55 15 20, elena-mihaela.cordeanu@chru-strasbourg.fr
About this study
Official title: Efficacy Cost Analysis: Retrospective Study on the REMOTEV Study's Ancillary Data
The implications of the medico-economic impact are essential in the choice of first-line therapists. The economic impact is an important criterion to recommend the privileged use of Direct Oral Anticoagulants (AOD) in first intention.
- Conditions
- Venous Thromboembolic Disease
- Keywords
- Venous, Thromboembolic, Direct Oral Anticoagulants, AOD, Cost analysis, REMOTEV, AVK, Pulmonary embolism
- Medical subject headings
- Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness analysis between 2 therapeutic strategies, Direct Oral Anticoagulants (Rivaroxaban) versus standard anticoagulant (AVK)
Cost-effectiveness analysis between 2 therapeutic strategies: The costs related to each strategy are calculated taking into account the direct and indirect costs.
Measured: The period from November 1st, 2013 to July 01, 2015 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start20 Mar 2019
- Primary completion20 Mar 2020 (estimated)
- Study completion20 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolic DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique STEPHAN, MD, PhD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887806
- Sponsor's protocol ID
- 7158
- Status last verified
- Mar 2019
- First submitted
- 20 Mar 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Cost Analysis: Retrospective Study on the REMOTEV Study's Ancillary Data
- ClinicalTrials.gov ID
- NCT03887806
- Acronym / sponsor ID
- 7158
- Conditions
- Venous Thromboembolic Disease
- Keywords
- Venous, Thromboembolic, Direct Oral Anticoagulants, AOD, Cost analysis, REMOTEV, AVK, Pulmonary embolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 20 Mar 2020 (estimated)
- Study completion
- 20 Mar 2020 (estimated)
- First posted
- 25 Mar 2019 (actual)
- 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.
The implications of the medico-economic impact are essential in the choice of first-line therapists. The economic impact is an important criterion to recommend the privileged use of Direct Oral Anticoagulants (AOD) in first intention.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a diagnosis of MTEV: pulmonary embolism or deep vein thrombosis diagnosed by the diagnostic reference methods according to the recommendations
Key inclusion criteria (9 listed)
- Major patient whose age is ≥18 years
- Patient with a diagnosis of MTEV: pulmonary embolism or deep vein thrombosis diagnosed by the diagnostic reference methods according to the recommendations
- Major patient included in the REMOTEV registry
- Patient having accepted that his data recorded in the REMOTEV register be re-used for research and publication purposes
- Criteria of non-inclusion
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cost-effectiveness analysis between 2 therapeutic strategies, Direct Oral Anticoagulants (Rivaroxaban) versus standard anticoagulant (AVK)
Time frame: The period from November 1st, 2013 to July 01, 2015 will be examined
Cost-effectiveness analysis between 2 therapeutic strategies: The costs related to each strategy are calculated taking into account the direct and indirect costs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
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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.
Dominique STEPHAN, MD, PhD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolic Disease, run by University Hospital, Strasbourg, France at 1 site in France.
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 9 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique STEPHAN, MD, PhD (33.3.69.55.09.52, dominique.stephan@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-effectiveness analysis between 2 therapeutic strategies, Direct Oral Anticoagulants (Rivaroxaban) versus standard anticoagulant (AVK) (time frame: The period from November 1st, 2013 to July 01, 2015 will be examined). 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 25 Mar 2019.