Clinical trial NCT03103763: Anticoagulation Therapy in the Very Old
Official title: ATIVO Study - Anticoagulation Therapy in the Very Old
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Elderly
Anticoagulation
Risk Assessment
Lead sponsor: MaineHealth
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 132
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients seen by the PBMC Anticoagulation Services who are taking warfarin, have atrial fibrillation aged 90 years and older will be invited to participate in the study. A matched cohort of patients aged 80-89 will also be enrolled as well as another matched cohort of patients aged 70-79 who are on warfarin for atrial fibrillation will be enrolled.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Experiencing Stroke
timeFrame: 24 months
measure: Number of Patients Experiencing a Major Bleeding Event
timeFrame: 24 months
Secondary outcomes:
measure: Number of Patients Experiencing a Traumatic Subdural Hemorrhage
timeFrame: 24 months
measure: Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage
timeFrame: 24 months
measure: Number of Hospitalizations Patients Experienced
timeFrame: 24 months
measure: Number of Patients Experiencing Cardiovascular Death
timeFrame: 24 months
measure: Number of Patients Experiencing Death Related to Anticoagulation
timeFrame: 24 months
measure: Mean Time in Therapeutic Range at End of Study Participation
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Rockport
country: United States
facility: Penobscot Bay Medical Center
state: Maine
Study officials:
affiliation: MaineHealth
name: Robert W. Stein, MD
role: PRINCIPAL_INVESTIGATOR
References: