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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 : Completed
First Posted : April 6, 2017
Results First Posted : June 16, 2020
Last Update Posted : June 16, 2020
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 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.

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Study Type : Observational
Actual Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ATIVO Study - Anticoagulation Therapy in the Very Old
Actual Study Start Date : March 20, 2017
Actual Primary Completion Date : September 3, 2019
Actual Study Completion Date : September 3, 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. 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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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.
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


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
  Study Documents (Full-Text)

Documents provided by Robert W. Stein, MD, Penobscot Bay Medical Center:
Study Protocol  [PDF] December 13, 2018
Statistical Analysis Plan  [PDF] March 13, 2020
Informed Consent Form  [PDF] March 20, 2017

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Responsible Party: Robert W. Stein, MD, Medical Director of Anticoagulation Services, Penobscot Bay Medical Center
ClinicalTrials.gov Identifier: NCT03103763    
Other Study ID Numbers: PenobscotBMC
First Posted: April 6, 2017    Key Record Dates
Results First Posted: June 16, 2020
Last Update Posted: June 16, 2020
Last Verified: June 2020
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