Phase 4
N=101
Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation
Dementia · Cognition Disorders · Cerebral Ischemic Events
Bottom Line
View on ClinicalTrials.gov: NCT03061006 ↗Enrolled (actual)
101
Serious AEs
34.7%
Results posted
May 2026
Primary outcome: Primary: Number of Participants With Incident Dementia Determined by a Formal Diagnosis of Dementia by a Neurologist — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dabigatran Etexilate (Drug); Warfarin (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Intermountain Health Care, Inc.
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Incident Dementia Determined by a Formal Diagnosis of Dementia by a Neurologist |
0; 0 | — |
| PRIMARY Number of Participants With Moderate Decline in Cognitive Function Based on Results of the Alzheimer's Disease Assessment Scale and the Disability Assessment for Dementia. |
5; 2 | 0.23 |
| SECONDARY Number of Participants With Stroke or Transient Ischemic Attack (TIA) or Intracranial Bleed |
2; 0 | 0.24 |
| SECONDARY Percent Change From Baseline in Mini-Mental State Examination Scores. |
4.3; 2.6 | 0.56 |
| SECONDARY Changes From Baseline Scores on the Hachinski Ischemic Scale |
7.3; 5.9 | 0.50 |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female >65 years of age.
- Non-valvular atrial fibrillation documented by electrocardiogram, ambulatory event monitor, or telemetry within 12 months of enrollment.
- Moderate risk of thromboembolism based upon a CHADS score or CHADS2 Vasc score of ≥2.
- Ability to complete a mini-mental status evaluation.
- Ability to independently comprehend and complete a quality of life and dementia questionnaires.
- Ability to provide informed consent for study participation.
- Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
Exclusion Criteria
- Inability to take an anticoagulant due to known or perceived bleeding risk.
- Known coagulopathy that may impact the choice, duration, efficacy and safety of anticoagulation therapy.
- Atrial Fibrillation in the setting of valvular heart disease. Valvular heart disease defined as any surgical valve, mitral stenosis, or moderate-severe valvular heart disease.
- Severe renal dysfunction, defined as a creatinine clearance rate <15 mL/min (documented within the last 3 months).
- History of any form of dementia.
- A life expectancy less than 24 months.
- Inability to comply with the follow-up schedule.
- Current participation in a clinical investigation that includes an active pharmacologic treatment arm.
- An upper age limit not to be used if participation inclusion criteria are met.
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
- Other conditions that in the opinion of the Principal Investigator(s) may increase risk to the subject and/or compromise the quality of the clinical trial.
- Concurrent pharmacologic treatment that is required to treat a condition long-term in which concurrent use of dabigatran etexilate is contraindicated.
- Treatment with any anticoagulant drug for stroke prevention for more than 30 days.
- Aspirin and P2Y12 inhibitors (e.g. clopidogrel (Plavix), or prasugrel (Effient)) are not considered anticoagulant drugs.
- If the subject has received any anticoagulant drug for stroke prevention for less than 30 days, the Principal Investigator(s) or a Co-Investigator will decide whether or not the subject is eligible for this study
- The Principal Investigator(s) determine(s) that the subject is not eligible for participation in this research study.
Data sourced from ClinicalTrials.gov (NCT03061006). 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.