Anticoagulation Therapy in the Very Old

An observational study of Atrial Fibrillation, run by Robert Stein at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 70 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Warfarin
How many people: 132 participants
Where: 1 siteUnited States
Study dates: 20 Mar 2017to 3 Sep 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 70 years and older
All sexes
No healthy volunteers
Older adult

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.

Who may be able to join

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

Who cannot join

Patients not being followed by the PBMC Anticoagulation Services

Trial locations and contacts

1 site in 1 country.

United States1 site

Penobscot Bay Medical Center
Rockport, Maine, 04856

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Atrial Fibrillation
Being tested: Warfarin
Keywords: Elderly, Anticoagulation, Risk Assessment
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WarfarinDrug
Also called Coumadin, Jantoven
Patients on warfarin for atrial fibrillation

Study groups in NCT03103763
Study group	Role	What they receive
Aged 90 and older		Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services. Receives: Drug: Warfarin
Aged 80-89		Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services. Receives: Drug: Warfarin
Aged 70-79		Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services. Receives: Drug: Warfarin

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients Experiencing Stroke
Every 6 months the medical record was reviewed for evidence of stroke of any cause.
Measured: 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
Measured: 24 months

Secondary outcomes (6)

Number of Patients Experiencing a Traumatic Subdural Hemorrhage
Number of subjects who experienced a traumatic subdural hemorrhage in each age group
Measured: 24 months
Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage
Number of subjects who experienced a traumatic intracerebral hemorrhage in each age group
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 20173 Sep 2019

First posted6 Apr 2017
Study start20 Mar 2017
Primary completion3 Sep 2019
Study completion3 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03103763
Sponsor's protocol ID: PenobscotBMC
Acronym: ATIVO
Status last verified: Aug 2021
First submitted: 1 Apr 2017
Last updated: 17 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: date will not be shared

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
Active, not recruitingObservational study
FARAPULSE™ Pulsed Field Ablation System
Paroxysmal AF
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruitingPhase 3
SGB for Prevention of Postop A-Fib After Cardiac SurgeryTrial
Atrial Fibrillation, Postoperative Atrial Fibrillation

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ATIVO Study - Anticoagulation Therapy in the Very Old
ClinicalTrials.gov ID: NCT03103763
Acronym / sponsor ID: ATIVO / PenobscotBMC
Conditions: Atrial Fibrillation
Keywords: Elderly, Anticoagulation, Risk Assessment
Study type: Observational
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: Robert SteinUniversity, hospital or other
Study start: 20 Mar 2017 (actual)
Primary completion: 3 Sep 2019 (actual)
Study completion: 3 Sep 2019 (actual)
First posted: 6 Apr 2017 (actual)
Results: Posted 16 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Aged 90 and older	–	Drug: WarfarinSubjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Aged 80-89	–	Drug: WarfarinSubjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Aged 70-79	–	Drug: WarfarinSubjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

Patients not being followed by the PBMC Anticoagulation Services

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WarfarinAlso: Coumadin, JantovenPatients on warfarin for atrial fibrillation	Drug	Aged 70-79, Aged 80-89, Aged 90 and older

Primary outcome

Number of Patients Experiencing Stroke
Time frame: 24 months
Every 6 months the medical record was reviewed for evidence of stroke of any cause.
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

6 secondary outcomes

Number of Patients Experiencing a Traumatic Subdural Hemorrhage
Time frame: 24 months
Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage
Time frame: 24 months
Number of Hospitalizations Patients Experienced
Time frame: 24 months
Number of Patients Experiencing Cardiovascular Death
Time frame: 24 months
Number of Patients Experiencing Death Related to Anticoagulation
Time frame: 24 months
Mean Time in Therapeutic Range at End of Study Participation
Time frame: up to 24 months

Results and safety

Results posted to the registry on 16 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aged 90 and Older	44	29
Aged 80-89	44	36
Aged 70-79	44	37

Primary outcome: Number of Patients Experiencing Stroke

Time frame: 24 months. Count of participants. Unit: Participants

Measure	Aged 90 and Older n = 44	Aged 80-89 n = 41	Aged 70-79 n = 42
Value	2	2	0

Population analysed: Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study.

Primary outcome: Number of Patients Experiencing a Major Bleeding Event

Time frame: 24 months. Count of participants. Unit: Participants

Measure	Aged 90 and Older n = 44	Aged 80-89 n = 41	Aged 70-79 n = 42
Value	4	2	4

Population analysed: Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Because the study is a registry, no events were collected as adverse events. Outcomes were collected. All cause mortality was collected from date of consent up to 24 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aged 90 and Older	0 of 0	0 of 0	15 of 44
Aged 80-89	0 of 0	0 of 0	5 of 41
Aged 70-79	0 of 0	0 of 0	5 of 42

Limitations and caveats (from the sponsor): The small sample size limits the power of this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. date will not be shared

Related trials for Atrial Fibrillation

Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
Active, not recruitingObservational study
FARAPULSE™ Pulsed Field Ablation System
Paroxysmal AF
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruitingPhase 3
SGB for Prevention of Postop A-Fib After Cardiac SurgeryTrial
Atrial Fibrillation, Postoperative Atrial Fibrillation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert W. Stein, MD principal investigator

MaineHealth

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Robert Stein at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Experiencing Stroke (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03103763.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021; AzTrials last refreshed its copy on 28 Oct 2026.