Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation (CAF)
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|ClinicalTrials.gov Identifier: NCT03061006|
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : June 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dementia Cognition Disorders Cerebral Ischemic Events||Drug: Dabigatran Etexilate Drug: Warfarin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation (CAF Trial)|
|Actual Study Start Date :||April 3, 2017|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Experimental: Dabigatran Etexilate
150 mg BID (CrCL > 30 mL/min) or 75 mg BID (CrCL 15-30 mL/min)
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.
Other Name: Pradaxa
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 Name: Coumadin
- 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
- 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.
- Stroke or Transient ischemic attack (TIA), intracranial bleed [ Time Frame: 24 months ]
- Changes from baseline scores on the mini-mental status evaluation and the Hachinski Ischemic Scale. [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061006
|Contact: T. Jared Bunch, MDfirstname.lastname@example.org|
|Contact: Patti Spenceremail@example.com|