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Can a common blood thinner shield your brain from dementia?
NCT ID NCT03061006
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed study looked at whether two different blood thinners—dabigatran (Pradaxa) and warfarin (Coumadin)—could help prevent memory loss and dementia in people over 65 with atrial fibrillation (an irregular heartbeat). A total of 101 participants were randomly assigned to take one of the two medications and were followed for two years. Researchers tracked changes in thinking skills, dementia diagnoses, and brain scans to see if one drug offered better protection for the brain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dabigatran etexilate (Pradaxa) and warfarin (Coumadin)
- What this could lead to
- If successful, this study could show that choosing dabigatran over warfarin helps preserve memory and thinking skills in older adults with atrial fibrillation.
- What could go wrong
- This is a small, completed Phase 4 trial with only 101 participants, so results may not apply to everyone. The study compares two existing drugs, so no new treatment is being developed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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101 people
The number who actually took part.
- Started
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Mar 2017
- Finished
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Mar 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female \>65 years of age. 2. Non-valvular atrial fibrillation documented by electrocardiogram, ambulatory event monitor, or telemetry within 12 months of enrollment. 3. Moderate risk of thromboembolism based upon a CHADS score or CHADS2 Vasc score of ≥2. 4. Ability to complete a mini-mental status evaluation. 5. Ability to independently comprehend and complete a quality of life and dementia questionnaires. 6. Ability to provide informed consent for study participation. 7. Willing and able to comply with the prescribed follow-up tests and schedule of evaluations. Exclusion Criteria: 1. Inability to take an anticoagulant due to known or perceived bleeding risk. 2. Known coagulopathy that may impact the choice, duration, efficacy and safety of anticoagulation therapy. 3. 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. 4. Severe renal dysfunction, defined as a creatinine clearance rate \<15 mL/min (documented within the last 3 months). 5. History of any form of dementia. 6. A life expectancy less than 24 months. 7. Inability to comply with the follow-up schedule. 8. Current participation in a clinical investigation that includes an active pharmacologic treatment arm. 9. An upper age limit not to be used if participation inclusion criteria are met. 10. Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study. 11. 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. 12. Concurrent pharmacologic treatment that is required to treat a condition long-term in which concurrent use of dabigatran etexilate is contraindicated. 13. 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 14. The Principal Investigator(s) determine(s) that the subject is not eligible for participation in this research study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Intermountain Heart Institute
Murray, Utah, 84143, United States
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