NCT03061006

Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation

Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation (CAF Trial)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dementia
• Cognition Disorders
• Cerebral Ischemic Events

Interventions

Type	Name	Description
DRUG	Dabigatran Etexilate	150 mg BID (CrCL \> 30 mL/min) or 75 mg BID (CrCL \> 15 to 30 mL/min); Assessment of kidney function every 6 months.
DRUG	Warfarin	Dose-adjusted (INR 2.0 - 3.0); Standard warfarin follow-up and education based upon system criteria.

Timeline

• Start date: 2017-04-03
• Primary completion: 2021-03-15
• Completion: 2021-03-15
• First posted: 2017-02-23
• Last updated: 2021-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study