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NCT03061006 · ClinicalTrials.gov registry record · Phase 4
Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation
A Phase 4 study, sponsored by Intermountain Health Care.
- Completed
- Registry status
- Phase 4
- Development phase
- 101
- Enrollment target
NCT03061006 is a Phase 4 study that has completed, run by Intermountain Health Care. The registered enrollment target is 101 participants.
The verdict
NCT03061006, a Phase 4 study, has completed, sponsored by Intermountain Health Care.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 101 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Warfarin
- DRUG Dabigatran Etexilate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2017-03-30 |
| Est. Completion | 2021-03-15 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03061006
The ClinicalTrials.gov registry entry for NCT03061006 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intermountain Health Care, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Warfarin is the first listed.
NCT03061006 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03061006 about?
NCT03061006 is a clinical study titled "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 crite...
What is the current status of trial NCT03061006?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 101 participants. The study started on 2017-03-30. Estimated completion is 2021-03-15.
What interventions are being tested in trial NCT03061006?
The interventions under investigation include: Warfarin (DRUG), Dabigatran Etexilate (DRUG).
Who is sponsoring clinical trial NCT03061006?
This trial is sponsored by Intermountain Health Care, which has 85 total clinical trials registered on ClinicalTrials.gov.
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