Anticoagulation Therapy in the Very Old (ATIVO)

Robert Stein

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Warfarin

Study type: Observational

Funder types: Other

Identifiers

NCT03103763

PenobscotBMC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 132 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

132 participants in 3 patient groups

Aged 90 and older

Description:

Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.

Treatment:

Drug: Warfarin

Aged 80-89

Description:

Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.

Treatment:

Drug: Warfarin

Aged 70-79

Description:

Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.

Treatment:

Drug: Warfarin