Anticoagulation Therapy in the Very Old (ATIVO)

ATIVO Study - Anticoagulation Therapy in the Very Old

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Warfarin

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.

• Study Type: Observational
• Enrollment (Actual): 132

Contacts and Locations

Study Locations

• United States
  • Maine
    • Rockport, Maine, United States, 04856
      • Penobscot Bay Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Robert Stein
• Investigators: Principal Investigator: Robert W. Stein, MD, MaineHealth

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Actual): September 3, 2019
• Study Completion (Actual): September 3, 2019

Study Registration Dates

• First Submitted: April 1, 2017
• First Submitted That Met QC Criteria: April 1, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 14, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Elderly; Anticoagulation; Risk Assessment
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Anticoagulants; Warfarin
• Other Study ID Numbers: PenobscotBMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: date will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No