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Completed

NCT Number: NCT03061006

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

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Cerebral Ischemic Events Cognition Disorders Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Intermountain Heart Institute

Murray, Utah, 84143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dabigatran Etexilate

Drug

150 mg BID (CrCL > 30 mL/min) or 75 mg BID (CrCL > 15 to 30 mL/min); Assessment of kidney function every 6 months.

Other names: Pradaxa

Warfarin

Drug

Dose-adjusted (INR 2.0 - 3.0); Standard warfarin follow-up and education based upon system criteria.

Other names: Coumadin

Primary outcomes

  1. Number of Participants With Incident Dementia Determined by a Formal Diagnosis of Dementia by a Neurologist

    Time frame: 24 months

    Incident dementia will be determined by a formal diagnosis of dementia by a neurologist

  2. 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.

    Time frame: 24 months

    Determined by measuring the change from baseline to study conclusion on the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog11, with scores ranging from 0 to 70, and higher scores indicating greater impairment) and the Disability Assessment for Dementia (DAD, with scores ranging from 0 to 100, and higher scores indicating less impairment). An increase in ADAS-cog11 of >30% is considered significant for moderate cognitive decline. In subjects that score <50% on the DAD, there is a direct correlation with global deterioration scales and scores. Subjects with a 30% decrease in DAD score or those with a score <50% will be considered to have moderate cognitive decline. These scores will be aggregated and if a patient meets either one of the cognitive decline definitions they will be deemed positive for cognitive impairment.

Secondary outcomes

  1. Number of Participants With Stroke or Transient Ischemic Attack (TIA) or Intracranial Bleed

    Time frame: 24 months

  2. Percent Change From Baseline in Mini-Mental State Examination Scores.

    Time frame: 24 months

    The Mini-Mental State Examination (MMSE) is commonly used to measure cognitive change over time. Scores on the MMSE range from 0 to 30. Any score of 24 or more indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. We measured the percent change from baseline scores.

  3. Changes From Baseline Scores on the Hachinski Ischemic Scale

    Time frame: 24 months

    The Hachinski Ischemic Scale (HIS) is commonly used clinical tool to differentiate between different types of dementia. Scores on the HIS range from 0 to 18. A score of less than 4 suggests primary dementia. A score of 4-7 is indeterminate. A score more than 7 suggests vascular dementia. We measured percentage change from baseline scores on the HIS.

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

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

Acronym: CAF

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2017
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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