- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03887806
Cost Effectiveness Analysis of an Ancillary Study of the REMOTEV Study
March 21, 2019 updated by: University Hospital, Strasbourg, France
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dominique STEPHAN, MD, PhD
- Phone Number: 33.3.69.55.09.52
- Email: Dominique.Stephan@chru-strasbourg.fr
Study Contact Backup
- Name: Elena-Mihaela CORDEANU, MD
- Phone Number: 33 3 69 55 15 20
- Email: elena-mihaela.cordeanu@chru-strasbourg.fr
Study Locations
-
-
-
Strasbourg, France, 67091
- Recruiting
- Service Des Maladies Vasculaires - Hta - Nhc
-
Contact:
- Dominique STEPHAN, MD, PhD
- Phone Number: 33.3.69.55.09.52
- Email: Dominique.Stephan@chru-strasbourg.fr
-
Contact:
- Elena-Mihaela CORDEANU, MD
- Phone Number: 33 3 69 55 15 20
- Email: elena-mihaela.cordeanu@chru-strasbourg.fr
-
Principal Investigator:
- Dominique STEPHAN, MD, PhD
-
Sub-Investigator:
- Elena-Mihaela CORDEANU, MD
-
Sub-Investigator:
- Sabrina GARNIER KEPKA, MD
-
Sub-Investigator:
- Sébastien GAERTNER, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient with a diagnosis of MTEV: pulmonary embolism or deep vein thrombosis diagnosed by the diagnostic reference methods according to the recommendations
Description
Inclusion criteria
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
The period from November 1st, 2013 to July 01, 2015 will be examined
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dominique STEPHAN, MD, PhD, University Hospital, Strasbourg, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2019
Primary Completion (Anticipated)
March 20, 2020
Study Completion (Anticipated)
March 20, 2020
Study Registration Dates
First Submitted
March 20, 2019
First Submitted That Met QC Criteria
March 21, 2019
First Posted (Actual)
March 25, 2019
Study Record Updates
Last Update Posted (Actual)
March 25, 2019
Last Update Submitted That Met QC Criteria
March 21, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7158 (Other Identifier: Oregon State University IRB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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