NCT03292575

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
441

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 4, 2019

Status Verified

June 1, 2019

Enrollment Period

2.9 years

First QC Date

September 21, 2017

Last Update Submit

June 3, 2019

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • rate of stroke recurrences

    12 months after inclusion

Study Arms (1)

Stroke related to CAAF

Drug: Anticoagulants

Interventions

AnticoagulantsDRUG
Stroke related to CAAF

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Conditions

Stroke

Interventions

Anticoagulants

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

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

Study Record Dates

First Submitted

September 21, 2017

First Posted

September 25, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

June 4, 2019

Record last verified: 2019-06

Locations

FR(1)