Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
55 participants
INTERVENTIONAL
2015-10-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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dabigatran 110mg or 150mg
After once enrolled, subjects will be randomized to dabigatran group. (110mg or 150mg twice a day)
dabigatran
After randomization, patients of this group was will be treated to dabigatran 110mg or 150mg twice a day for 24months
ribaroxaban 20mg
After once enrolled, subjects will be randomized to ribaroxaban group. (20mg once daily)
ribaroxaban
After randomization, patients of this group was will be treated to ribaroxaban 20mg once a day for 24months.
warfarin
After once enrolled, subjects will be randomized to warfarin group. (controlled by INR 2-3)
Warfarin
After randomization, patients of this group was will be treated to warfarin and controlled by INR 2-3 for 24months.
Interventions
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dabigatran
After randomization, patients of this group was will be treated to dabigatran 110mg or 150mg twice a day for 24months
ribaroxaban
After randomization, patients of this group was will be treated to ribaroxaban 20mg once a day for 24months.
Warfarin
After randomization, patients of this group was will be treated to warfarin and controlled by INR 2-3 for 24months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* grade 4 or higher cerebral infarction on the Modified Rankin Scale
* proven coronary artery disease by coronary angiogram
* severe hepatic or renal dysfunction
* uncontrolled congestive heart failure
* uncontrolled hypertension or diabetes mellitus
* hematologic disorders
* allergy or hypersensitivity to the investigational drugs
* pregnant or lactating women or women wishing to become pregnant
40 Years
85 Years
ALL
Yes
Sponsors
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Kyunghee University Medical Center
OTHER
Responsible Party
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Weon Kim
professor
Principal Investigators
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Weon Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kyunghee University Medical Center
Locations
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Kyung Hee University
Seoul, , South Korea
Countries
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Central Contacts
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References
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Kim JB, Joung HJ, Lee JM, Woo JS, Kim WS, Kim KS, Lee KH, Kim W. Evaluation of the vascular protective effects of new oral anticoagulants in high-risk patients with atrial fibrillation (PREFER-AF): study protocol for a randomized controlled trial. Trials. 2016 Aug 24;17(1):422. doi: 10.1186/s13063-016-1541-8.
Other Identifiers
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PREFER-AF
Identifier Type: -
Identifier Source: org_study_id
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