Anticoagulation Therapy in the Very Old

Atrial Fibrillation Clinical Trial

— ATIVO  

Official title:

ATIVO Study - Anticoagulation Therapy in the Very Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103763
• Other study ID #: PenobscotBMC
• Status: Completed
• Start date: March 20, 2017
• Est. completion date: September 3, 2019

Study information

• Verified date: August 2021
• Source: MaineHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: September 3, 2019
• Est. primary completion date: September 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Warfarin
Patients on warfarin for atrial fibrillation

Locations

Country	Name	City	State
United States	Penobscot Bay Medical Center	Rockport	Maine

Sponsors (1)

Lead Sponsor	Collaborator
Robert Stein

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Experiencing Stroke	Every 6 months the medical record was reviewed for evidence of stroke of any cause.	24 months
Primary	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	Number of Patients Experiencing a Traumatic Subdural Hemorrhage	Number of subjects who experienced a traumatic subdural hemorrhage in each age group	24 months
Secondary	Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage	Number of subjects who experienced a traumatic intracerebral hemorrhage in each age group	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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