Anticoagulation Therapy in the Very Old

NCT03103763 | Completed Results

• 1 other identifier: PenobscotBMC
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Elderly; Anticoagulation; Risk Assessment

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Number of Patients Experiencing a Traumatic Subdural Hemorrhage

  24 months

• Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage

  24 months

• Number of Hospitalizations Patients Experienced

  24 months

• Number of Patients Experiencing Cardiovascular Death

  24 months

• Number of Patients Experiencing Death Related to Anticoagulation

  24 months

Study Arms (3)

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

Aged 80-89

Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.

Drug: Warfarin

Aged 70-79

Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.

Drug: Warfarin

Interventions

Warfarin DRUG

Patients on warfarin for atrial fibrillation

Also known as: Coumadin, Jantoven

Aged 70-79; Aged 80-89; Aged 90 and older

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- Patients not being followed by the PBMC Anticoagulation Services

Sponsors & Collaborators

• Robert Stein: lead

Study Sites (1)

Penobscot Bay Medical Center

Rockport, Maine, 04856, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Warfarin; Vitamin B 6

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Picolines; Pyridines

Limitations and Caveats

The small sample size limits the power of this study.

Results Point of Contact

• Title: Caroline Knight, RN, Clinical Research Manager
• Organization: Penobscot Bay Medical Center

cknight@pbmc.org

207-301-8959

Study Officials

• Robert W. Stein, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director of Anticoagulation Services

Study Record Dates

• First Submitted: April 1, 2017
• First Posted: April 6, 2017
• Study Start: March 20, 2017
• Primary Completion: September 3, 2019
• Study Completion: September 3, 2019
• Last Updated: August 17, 2021
• Results First Posted: June 16, 2020

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)