AOD: Study of the Follow-up of Stroke Treated With Anticoagulants

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Completed
• CT.gov ID: NCT03292575
• Collaborator: (none)
• Enrollment: 441
• Location: 1
• Actual Duration (Months): 35
• Patients Per Site Per Month: 12.6

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Stroke	Drug: Anticoagulants

Study Design

• Study Type: Observational
• Actual Enrollment: 441 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prevention of Cardio-embolic Stroke Using Anti-vitamin K and Direct Oral Anticoagulants. A Model of Action in Burgundy.
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Stroke related to CAAF	Drug: Anticoagulants

Outcome Measures

Primary Outcome Measures

1. rate of stroke recurrences [12 months after inclusion]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• NA

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Dijon Bourgogne	Dijon		France	21079

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT03292575
• Other Study ID Numbers: Giroud 2016
• First Posted: Sep 25, 2017
• Last Update Posted: Jun 4, 2019
• Last Verified: Jun 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke; Anticoagulants

Study Results

No Results Posted as of Jun 4, 2019