Anticoagulation Therapy in the Very Old

Study Overview
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Brief Summary
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This study is designed to evaluate the efficacy and safety of warfarin anticoagulation in the very old and attempt to identify risk factors which may impede safe and effective anticoagulation.

Detailed Description
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This is a prospective registry study with data being collected continuously for 24 months. Patients who have electrocardiographically confirmed atrial fibrillation, are being followed by the Pen Bay Medical Center Anticoagulation Services and are at least 90 years old will be recruited into the study. A matched cohort of patients between the ages of 80 and 89 and another matched cohort of patients between the ages of 70 and 79 will also be recruited into the study for comparison. Data related to adverse events, concomitant medications, living arrangements, mobility and alcohol use will be collected every 6 months. In addition the CHA2DS2-VASc (score for atrial fibrillation stroke risk), HAS - BLED (major bleeding risk score for patients on anticoagulation), frailty and Mini Cog scores will be recalculated at each visit.

Official Title
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ATIVO Study - Anticoagulation Therapy in the Very Old

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 70 years of age or older electrocardiographically confirmed atrial fibrillation anticipated regular follow up with patient by Penobscot Bay Medical Center (PBMC) Anticoagulation Services Subject or legally authorized representative must be willing to provide informed consent Exclusion Criteria: - Patients not being followed by the PBMC Anticoagulation Services

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aged 90 and older<br>Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services. | Drug: Warfarin<br>* Patients on warfarin for atrial fibrillation<br>* Other names: Coumadin, Jantoven;|
| Aged 80-89<br>Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services. | Drug: Warfarin<br>* Patients on warfarin for atrial fibrillation<br>* Other names: Coumadin, Jantoven;|
| Aged 70-79<br>Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services. | Drug: Warfarin<br>* Patients on warfarin for atrial fibrillation<br>* Other names: Coumadin, Jantoven;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Experiencing Stroke | Every 6 months the medical record was reviewed for evidence of stroke of any cause. | 24 months | 
| Number of Patients Experiencing a Major Bleeding Event | defined as one of the following: fatal bleeding, symptomatic bleeding in a critical area or organ or bleeding causing a fall in hemoglobin of 2 g/dl or more or leading to a transfusion of 2 or more units of whole blood or red cells | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Experiencing a Traumatic Subdural Hemorrhage | Number of subjects who experienced a traumatic subdural hemorrhage in each age group | 24 months | 
| Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage | Number of subjects who experienced a traumatic intracerebral hemorrhage in each age group | 24 months | 
| Number of Hospitalizations Patients Experienced | Every 6 months the medical record was reviewed for any hospitalizations experienced by the subject within our healthcare system. | 24 months | 
| Number of Patients Experiencing Cardiovascular Death | Every 6 months the medical record was reviewed. All deaths were researched for cause and noted if the cause was related to the cardiovascular system. | 24 months | 
| Number of Patients Experiencing Death Related to Anticoagulation | All deaths were reviewed in the medical record to determine the cause and if it was related in any way to the use of anticoagulation therapy. | 24 months | 
| Mean Time in Therapeutic Range at End of Study Participation | International Normalized Ratio (INR) time in therapeutic range at the end of the individual's study participation. | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Anticoagulation, Risk Assessment