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

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

Study Contact Backup

Study Locations

      • Strasbourg, France, 67091
        • Recruiting
        • Service Des Maladies Vasculaires - Hta - Nhc
        • Contact:
        • Contact:
        • 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

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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