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Can a common blood thinner shield your brain from dementia?

NCT ID NCT03061006

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

101 people

The number who actually took part.

Started

Mar 2017

Finished

Mar 2021

Lead sponsor

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

65 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Intermountain Heart Institute

    Murray, Utah, 84143, United States

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