Trial Outcomes & Findings for Anticoagulation Therapy in the Very Old (NCT NCT03103763)
NCT ID: NCT03103763
Last Updated: 2021-08-17
Results Overview
Every 6 months the medical record was reviewed for evidence of stroke of any cause.
Recruitment status
COMPLETED
Target enrollment
132 participants
Primary outcome timeframe
24 months
Results posted on
2021-08-17
Participant Flow
Participant milestones
| Measure |
Aged 90 and Older
Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 80-89
Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 70-79
Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
44
|
|
Overall Study
COMPLETED
|
29
|
36
|
37
|
|
Overall Study
NOT COMPLETED
|
15
|
8
|
7
|
Reasons for withdrawal
| Measure |
Aged 90 and Older
Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 80-89
Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 70-79
Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
|---|---|---|---|
|
Overall Study
Death
|
15
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
2
|
Baseline Characteristics
Anticoagulation Therapy in the Very Old
Baseline characteristics by cohort
| Measure |
Aged 90 and Older
n=44 Participants
Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 80-89
n=44 Participants
Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 70-79
n=44 Participants
Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Age, Continuous
|
93 years
n=5 Participants
|
84 years
n=7 Participants
|
74 years
n=5 Participants
|
84 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
44 participants
n=7 Participants
|
44 participants
n=5 Participants
|
132 participants
n=4 Participants
|
|
Living at home alone
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Living at home with paid help
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Living at home with family
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Living in assisted living
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Living in Long Term Care
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study.
Every 6 months the medical record was reviewed for evidence of stroke of any cause.
Outcome measures
| Measure |
Aged 90 and Older
n=44 Participants
Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 80-89
n=41 Participants
Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 70-79
n=42 Participants
Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
|---|---|---|---|
|
Number of Patients Experiencing Stroke
|
2 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study.
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
Outcome measures
| Measure |
Aged 90 and Older
n=44 Participants
Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 80-89
n=41 Participants
Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 70-79
n=42 Participants
Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
|---|---|---|---|
|
Number of Patients Experiencing a Major Bleeding Event
|
4 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study.
Number of subjects who experienced a traumatic subdural hemorrhage in each age group
Outcome measures
| Measure |
Aged 90 and Older
n=44 Participants
Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 80-89
n=41 Participants
Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 70-79
n=42 Participants
Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
|---|---|---|---|
|
Number of Patients Experiencing a Traumatic Subdural Hemorrhage
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study.
Number of subjects who experienced a traumatic intracerebral hemorrhage in each age group
Outcome measures
| Measure |
Aged 90 and Older
n=44 Participants
Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 80-89
n=41 Participants
Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 70-79
n=42 Participants
Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
|---|---|---|---|
|
Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study.
Every 6 months the medical record was reviewed for any hospitalizations experienced by the subject within our healthcare system.
Outcome measures
| Measure |
Aged 90 and Older
n=44 Participants
Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 80-89
n=41 Participants
Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 70-79
n=42 Participants
Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
|---|---|---|---|
|
Number of Hospitalizations Patients Experienced
|
51 hospitalizations
|
41 hospitalizations
|
41 hospitalizations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study.
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.
Outcome measures
| Measure |
Aged 90 and Older
n=44 Participants
Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 80-89
n=41 Participants
Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 70-79
n=42 Participants
Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
|---|---|---|---|
|
Number of Patients Experiencing Cardiovascular Death
|
15 Participants
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study.
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.
Outcome measures
| Measure |
Aged 90 and Older
n=44 Participants
Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 80-89
n=41 Participants
Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 70-79
n=42 Participants
Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
|---|---|---|---|
|
Number of Patients Experiencing Death Related to Anticoagulation
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 24 monthsPopulation: All subjects were included in this analysis.
International Normalized Ratio (INR) time in therapeutic range at the end of the individual's study participation.
Outcome measures
| Measure |
Aged 90 and Older
n=44 Participants
Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 80-89
n=44 Participants
Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
Aged 70-79
n=44 Participants
Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation
|
|---|---|---|---|
|
Mean Time in Therapeutic Range at End of Study Participation
|
72 percent of time in therapeutic range
Standard Deviation 17
|
76 percent of time in therapeutic range
Standard Deviation 18
|
70 percent of time in therapeutic range
Standard Deviation 17
|
Adverse Events
Aged 90 and Older
Serious events: 0 serious events
Other events: 0 other events
Deaths: 15 deaths
Aged 80-89
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Aged 70-79
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Caroline Knight, RN, Clinical Research Manager
Penobscot Bay Medical Center
Phone: 207-301-8959
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place