Study of the Follow-up of Stroke Treated With Anticoagulants (AOD)

June 3, 2019 updated by: Centre Hospitalier Universitaire Dijon

Prevention of Cardio-embolic Stroke Using Anti-vitamin K and Direct Oral Anticoagulants. A Model of Action in Burgundy.

Stroke is a major public health problem as it is very frequent (140,000 cases/year in France), and very serious (leading cause of death, 2nd leading cause of dementia, 3rd leading cause of handicap). Ischemic cardio-embolic stroke accounts for around 25% of ischemic strokes, and ischemic cardio-embolic stroke in a context of cardiac arrhythmia due to atrial fibrillation (CAAF) is the leading non-atheromatous cause. The aim of this study is to optimise the secondary prevention of CAAF-related stroke identified at the University Hospital of Dijon Burgundy in the framework of the recommendations of the '2010-2014 stroke plan' and the Compulsory Consultation at the 6th month (Directive DGOS//2015/262 of the 3rd August 2015)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

441

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU Dijon Bourgogne

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patient with stroke resulting from occlusion of a cerebral artery (cerebral infarction) with a clot detached from the heart that exhibits an arrhythmia by Auricular Fibrillation or the occurrence of intracerebral hemorrhage

Description

Inclusion Criteria:

  • patients managed for stroke at the stroke unit of Dijon University Hospital for CAAF-related cardio-embolic stroke

Exclusion Criteria:

  • NA

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stroke related to CAAF
Drug: Anticoagulants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of stroke recurrences
Time Frame: 12 months after inclusion
12 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

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)

January 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

September 21, 2017

First Submitted That Met QC Criteria

September 21, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

June 3, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Giroud 2016

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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