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Apixaban in Patients Who Undergo CIED Procedure- Randomized Pilot Study (Apixaban)

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ClinicalTrials.gov Identifier: NCT02450682
Recruitment Status : Withdrawn
First Posted : May 21, 2015
Last Update Posted : January 18, 2016
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Yong-Mei Cha, Mayo Clinic

Brief Summary:
This study is being done to determine if apixaban is more safe, when compared to warfarin, at reducing the risk of bleeding during CIED procedures.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Apixaban Drug: Warfarin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Evaluate the Safety of Apixaban in Patients Who Undergo Cardiovascular Implantable Electronic Device (CIED) Procedure: A Randomized Pilot Study
Study Start Date : February 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Apixaban
30 participants prescribed Apixaban 3-14 days before and 28 days after CIED procedure.
Drug: Apixaban
Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change
Other Name: Eliquis

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.
Drug: Warfarin
Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change
Other Name: Coumadin




Primary Outcome Measures :
  1. decrease in the hemoglobin level of 2 g per deciliter or more [ Time Frame: 2 months ]
    Assess the risk of major bleeding when continuing apixaban through the procedure as compared to Warfarin.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Signed informed written consent
  2. Patients are taking warfarin or apixaban chronically
  3. Patients are at risk of stroke or systemic embolism
  4. Patients have NVAF
  5. Patients will undergo CIED generator change
  6. Age 18-90
  7. Either gender
  8. All eligibility criteria must be met

Exclusion:

  1. Patient is critically ill, or in unstable condition
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450682


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Bristol-Myers Squibb
Investigators
Principal Investigator: Yong-Mei Cha, MD Mayo Clinic
Principal Investigator: Samuel Asirvatham, MD Mayo Clinic

Responsible Party: Yong-Mei Cha, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02450682     History of Changes
Other Study ID Numbers: 14-005395
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Apixaban
Warfarin
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action