SAGE-AF Study Fibrillation (SAGE-AF) Study
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
No interventions cited
University of Massachusetts, Worcester -- H00009079
University of Massachusetts, Worcester
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.
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
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.
65 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (1)
|University of Massachusetts Medical School - Worcester, Massachusetts||105.6 miles||Michelle Maynard||508-856-6915||SAGE-AF@umassmed.edu|