SAGE-AF Study Fibrillation (SAGE-AF) Study

Description

The goal of this research is to enhance anti-coagulant (AC) decision-making in older patients with atrial fibrillation using a geriatric assessment and identifying important factors that affect their use and important anticoagulant use outcomes (e.g., bleeding, time in therapeutic range).

Study Start Date

June, 27 2016

Estimated Completion Date

January 2020

Interventions

No interventions cited

Study ID

University of Massachusetts, Worcester -- H00009079

Status

Unknown

Trial ID

NCT03479281

Study Type

Observational

Trial Phase

Not Listed

Enrollment Quota

1200

Sponsor

University of Massachusetts, Worcester

Inclusion Criteria

    1. Age 65 and older, 2. Diagnosis of AF (12-lead electrocardiogram showing AF or previous note [within 12 months] documenting AF will be needed to confirm eligibility) 3. CHA2DS2VASc score ?2. 4. Capacity to provide informed consent as assessed by a Capacity instrument that combines direct questions about their understanding of study participation with interviewer observations of the patient. If the patient fails the Capacity assessment, they will be excluded.

Exclusion Criteria

    1. Absolute or relative contraindication to AC, including: 2. Active major bleeding. 3. Large esophageal varices. 4. Recent major surgery (<72 hours). 5. Recent (<3 months) major bleeding. 6. Arteriovenous malformation or aneurysm. 7. Planned invasive procedure with high risk for uncontrollable bleeding (e.g., open surgical procedure). 8. Decompensated liver disease. 9. Significant thrombocytopenia (platelet count <50k). 10. Documented hypersensitivity/allergic reaction to oral AC. 11. Indication for AC other than AF, e.g. ventricular thrombus or mechanical mitral valve. 12. Do not speak English. 13. Plan to move from their current residence in the next 2 years. 14. Do not provide informed consent for all study measures. 15. Are Women who are pregnant. 16. Prisoners

Gender

All

Ages

65 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
University of Massachusetts Medical School - Worcester, Massachusetts 105.6 miles Michelle Maynard 508-856-6915 SAGE-AF@umassmed.edu

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