NCT03887806

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 20, 2019

Last Update Submit

March 21, 2019

Conditions

Keywords

VenousThromboembolicDirect Oral AnticoagulantsAODCost analysisREMOTEVAVKPulmonary embolism

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Des Maladies Vasculaires - Hta - Nhc

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Dominique STEPHAN, MD, PhD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 25, 2019

Study Start

March 20, 2019

Primary Completion

March 20, 2020

Study Completion

March 20, 2020

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations