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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aged 90 and older | Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services. |
| |
| Aged 80-89 | Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services. |
| |
| Aged 70-79 | Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug | Patients on warfarin for atrial fibrillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Experiencing Stroke | Every 6 months the medical record was reviewed for evidence of stroke of any cause. | 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 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Experiencing a Traumatic Subdural Hemorrhage | Number of subjects who experienced a traumatic subdural hemorrhage in each age group | 24 months |
| Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage |
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Inclusion Criteria:
Exclusion Criteria:
- Patients not being followed by the PBMC Anticoagulation Services
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Robert W. Stein, MD | MaineHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penobscot Bay Medical Center | Rockport | Maine | 04856 | United States |
date will not be shared
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Aged 80-89 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Experiencing Stroke | Every 6 months the medical record was reviewed for evidence of stroke of any cause. | Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study. | Posted | Count of Participants | Participants | 24 months |
|
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.
Death information was available. However, serious and other adverse event data were not monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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The small sample size limits the power of this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline Knight, RN, Clinical Research Manager | Penobscot Bay Medical Center | 207-301-8959 | cknight@pbmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 13, 2018 | Mar 12, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 13, 2020 | Mar 13, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 20, 2017 | Mar 13, 2020 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| D025101 | Vitamin B 6 |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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Number of subjects who experienced a traumatic intracerebral hemorrhage in each age group
| 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. | 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. | 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. | 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. | up to 24 months |
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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Living at home alone | Count of Participants | Participants |
|
| Living at home with paid help | Count of Participants | Participants |
|
| Living at home with family | Count of Participants | Participants |
|
| Living in assisted living | Count of Participants | Participants |
|
| Living in Long Term Care | Count of Participants | Participants |
|
| OG002 | 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 |
|
|
| Primary | 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 | Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Number of Patients Experiencing a Traumatic Subdural Hemorrhage | Number of subjects who experienced a traumatic subdural hemorrhage in each age group | Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage | Number of subjects who experienced a traumatic intracerebral hemorrhage in each age group | Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Number of Hospitalizations Patients Experienced | Every 6 months the medical record was reviewed for any hospitalizations experienced by the subject within our healthcare system. | Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study. | Posted | Number | hospitalizations | 24 months |
|
|
|
| Secondary | 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. | Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | 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. | Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | 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. | All subjects were included in this analysis. | Posted | Mean | Standard Deviation | percent of time in therapeutic range | up to 24 months |
|
|
|
| 15 |
| 44 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 5 | 41 | 0 | 0 | 0 | 0 |
| EG002 | 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 | 5 | 42 | 0 | 0 | 0 | 0 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010847 | Picolines |
| D011725 | Pyridines |