N/A N=132

Anticoagulation Therapy in the Very Old

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT03103763 ↗

Enrolled (actual)

132

Serious AEs

—

Results posted

Jun 2020

Primary outcome: Primary: Number of Patients Experiencing Stroke — 2; 2; 0 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Warfarin (Drug)
Age: Older Adult · 70+ yrs
Sex: All
Sponsor: Robert Stein
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Experiencing Stroke	2; 2; 0	—
PRIMARY Number of Patients Experiencing a Major Bleeding Event	4; 2; 4	—
SECONDARY Number of Patients Experiencing a Traumatic Subdural Hemorrhage	0; 0; 0	—
SECONDARY Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage	0; 0; 0	—
SECONDARY Number of Hospitalizations Patients Experienced	51; 41; 41	—
SECONDARY Number of Patients Experiencing Cardiovascular Death	15; 5; 5	—
SECONDARY Number of Patients Experiencing Death Related to Anticoagulation	0; 0; 0	—
SECONDARY Mean Time in Therapeutic Range at End of Study Participation	72; 76; 70	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03103763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.