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Anticoagulation Therapy in the Very Old (ATIVO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103763
Recruitment Status : Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Robert W. Stein, MD, Penobscot Bay Medical Center

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Warfarin

Detailed Description:

This is a prospective registry study with data being collected continuously for 24 months.

Patients who have electocardiographically 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, HAS - BLED, frailty and Mini Cog scores will be recalculated at each visit.


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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ATIVO Study - Anticoagulation Therapy in the Very Old
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Coumadin, Jantoven




Primary Outcome Measures :
  1. Stroke [ Time Frame: 24 months ]
    all cause stroke

  2. Major bleeding [ 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 Outcome Measures :
  1. Cardiovascular events [ Time Frame: 24 months ]
    non stroke cardiovascular events

  2. Traumatic subdural hemorrhage [ Time Frame: 24 months ]
    Traumatic subdural hemorrhage

  3. Traumatic intracerebral hemorrhage [ Time Frame: 24 months ]
    Traumatic intracerebral hemorrhage

  4. Hospitalizations [ Time Frame: 24 months ]
    number of hospitalizations for any reason

  5. Cardiovascular death [ Time Frame: 24 months ]
    death secondary to cardiovascular cuases

  6. Anticoagulation death [ Time Frame: 24 months ]
    death secondary to anticoagulation

  7. Time in therapeutic range [ Time Frame: 24 months ]
    International Normalized Ratio (INR) time in therapeutic range for 2 years as well as best and worst 6 month



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients seen by the Penobscot Bay Medical Center 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.
Criteria

Inclusion Criteria:

  • 70 years of age or older
  • electrocardiographically confirmed atrial fibrillation
  • anticipated regular follow up with patient by 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103763


Locations
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United States, Maine
Penobscot Bay Medical Center
Rockport, Maine, United States, 04856
Sponsors and Collaborators
Robert W. Stein, MD
Investigators
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Principal Investigator: Robert W. Stein, MD Penobscot Bay Medical Center

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Responsible Party: Robert W. Stein, MD, Medical Director of Anticoagulation Services, Penobscot Bay Medical Center
ClinicalTrials.gov Identifier: NCT03103763     History of Changes
Other Study ID Numbers: PenobscotBMC
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: date will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert W. Stein, MD, Penobscot Bay Medical Center:
Elderly
Anticoagulation
Risk Assessment
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants