Cost Effectiveness Analysis of an Ancillary Study of the REMOTEV Study

Venous Thromboembolic Disease Clinical Trial

Official title:

Efficacy Cost Analysis: Retrospective Study on the REMOTEV Study's Ancillary Data

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03887806
• Other study ID #: 7158
• Status: Recruiting
• Start date: March 20, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: March 2019
• Source: University Hospital, Strasbourg, France
• Contact: Dominique STEPHAN, MD, PhD
• Phone: 33.3.69.55.09.52
• Email: dominique.stephan[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolic Disease

Locations

Country	Name	City	State
France	Service Des Maladies Vasculaires - Hta - Nhc	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The period from November 1st, 2013 to July 01, 2015 will be examined