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Completed

NCT Number: NCT03103763

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Penobscot Bay Medical Center

Rockport, Maine, 04856, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Warfarin

Drug

Patients on warfarin for atrial fibrillation

Other names: Coumadin, Jantoven

Primary outcomes

  1. Number of Patients Experiencing Stroke

    Time frame: 24 months

    Every 6 months the medical record was reviewed for evidence of stroke of any cause.

  2. Number of Patients Experiencing a Major Bleeding Event

    Time frame: 24 months

    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

Secondary outcomes

  1. Number of Patients Experiencing a Traumatic Subdural Hemorrhage

    Time frame: 24 months

    Number of subjects who experienced a traumatic subdural hemorrhage in each age group

  2. Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage

    Time frame: 24 months

    Number of subjects who experienced a traumatic intracerebral hemorrhage in each age group

  3. Number of Hospitalizations Patients Experienced

    Time frame: 24 months

    Every 6 months the medical record was reviewed for any hospitalizations experienced by the subject within our healthcare system.

  4. Number of Patients Experiencing Cardiovascular Death

    Time frame: 24 months

    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.

  5. Number of Patients Experiencing Death Related to Anticoagulation

    Time frame: 24 months

    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.

  6. Mean Time in Therapeutic Range at End of Study Participation

    Time frame: up to 24 months

    International Normalized Ratio (INR) time in therapeutic range at the end of the individual's study participation.

Sponsors and collaborators

Lead sponsor

Robert Stein

Other

Registry information

Official study title

ATIVO Study - Anticoagulation Therapy in the Very Old

Acronym: ATIVO

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 6, 2017
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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