- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03061006
Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation (CAF)
August 30, 2021 updated by: Intermountain Health Care, Inc.
Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation (CAF Trial)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Utah
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Murray, Utah, United States, 84143
- Intermountain Heart Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dabigatran Etexilate
150 mg BID (CrCL > 30 mL/min) or 75 mg BID (CrCL 15-30 mL/min)
|
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:
|
Active Comparator: Warfarin
Dose-adjusted warfarin (INR: 2.0-3.0)
|
Dose-adjusted (INR 2.0 - 3.0); Standard warfarin follow-up and education based upon system criteria.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incident dementia determined by a formal diagnosis of dementia by a neurologist
Time Frame: 24 months
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Incident dementia will be determined by a formal diagnosis of dementia by a neurologist
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24 months
|
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.
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24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stroke or Transient ischemic attack (TIA), intracranial bleed
Time Frame: 24 months
|
24 months
|
Changes from baseline scores on the mini-mental status evaluation and the Hachinski Ischemic Scale.
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2017
Primary Completion (Actual)
March 15, 2021
Study Completion (Actual)
March 15, 2021
Study Registration Dates
First Submitted
February 9, 2017
First Submitted That Met QC Criteria
February 17, 2017
First Posted (Actual)
February 23, 2017
Study Record Updates
Last Update Posted (Actual)
September 2, 2021
Last Update Submitted That Met QC Criteria
August 30, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Dementia
- Cognitive Dysfunction
- Cognition Disorders
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Dabigatran
- Warfarin
Other Study ID Numbers
- 1050164
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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