Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation
Status:
Completed
Trial end date:
2021-03-15
Target enrollment:
Participant gender:
Summary
Patients will be screened at Intermountain Medical Center and at Intermountain-affiliated
anticoagulation clinics in the Salt Lake City region. Patients with non-valvular atrial
fibrillation will be considered for study. After written informed consent is obtained,
subjects who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Group 1:
Dabigatran etexilate (150 mg BID if CrCL > 30 mL/min, or 75 mg BID if CrCL > 15 to 30 mL/min
or per USPI; and Group 2: Warfarin (Dose-adjusted (INR 2.0 - 3.0). Assessment of kidney
function every 6 months will be done for Group 1. Standard warfarin follow-up and education,
based upon system criteria, will be done for Group 2. All subjects will be followed for 24
months, and will be assessed at 1-week, then 3-, 6-, 12-, 18- and 24-months
post-anticoagulation visits as well as other visits deem necessary for clinical care. All
subjects will undergo protocol-specified laboratory tests and will complete 6 standard,
validated questionnaires at each follow-up visit following the week 1 visit, except at the
3-month visit when only one questionnaire will be administered. To determine brain volume and
characteristic changes representative of micro-bleeding, the first 10 subjects in each
treatment group who are willing and able to undergo the procedure will participate in a MRI
sub-study. The cranial MRI will be done at baseline and at 24-months post-anticoagulation on
this sub-group.