Apixaban in Patients Who Undergo CIED Procedure- Randomized Pilot Study
NCT ID: NCT02450682
Last Updated: 2016-01-18
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2016-02-29
2017-03-31
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
NONE
Study Groups
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Apixaban
30 participants prescribed Apixaban 3-14 days before and 28 days after CIED procedure.
Apixaban
Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change
Warfarin
30 participants will take stable dose of warfarin and go through the procedure without drug interrupt. The dose is adjusted by INR level. Length of treatment is 42 days, 14 days before and 28 days after the procedure.
Warfarin
Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change
Interventions
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Apixaban
Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change
Warfarin
Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
2. Patient is at high risk for bleeding, HAS-BLED score ≥ 3
3. Patient is required to take dual antiplatelet agents in addition to anticoagulant drug. (e.g. recent cardiac stent placement)
4. Patients have mechanical cardiac valve or another condition other than NVAF that requires chronic anticoagulation
5. Women of childbearing potential with positive pregnant test
6. Bilirubin \>2x upper limit of normal, in association with AST/ALT/ALP \>3x upper limit normal
7. Allergy to apixaban and warfarin
8. Subjects requiring taking strong dual inhibitors of CYP3A4 and P-gp who already meet the criteria to take 2.5 mg apixaban
9. Subjects requiring taking strong dual inducers of CYP3A4 and P-gp (.e.g., rifampin, carbamazepine, phenytoin, St. John's wort)
10. Patients who take any investigational drugs within 30 days of enrolling in study.
11. Prisoners or subjects who are involuntarily incarcerated.
12. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
18 Years
90 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Yong-Mei Cha
PI
Principal Investigators
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Yong-Mei Cha, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Samuel Asirvatham, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Other Identifiers
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14-005395
Identifier Type: -
Identifier Source: org_study_id
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