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Apixaban in Patients Who Undergo CIED Procedure- Randomized Pilot Study

Evaluate the Safety of Apixaban in Patients Who Undergo Cardiovascular Implantable Electronic Device (CIED) Procedure: A Randomized Pilot Study

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02450682
Acronym
Apixaban
Enrollment
0
Registered
2015-05-21
Start date
2016-02-29
Completion date
2017-03-31
Last updated
2016-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

DRUGApixaban

Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change

DRUGWarfarin

Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change

Sponsors

Bristol-Myers Squibb
CollaboratorINDUSTRY
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
decrease in the hemoglobin level of 2 g per deciliter or more2 monthsAssess the risk of major bleeding when continuing apixaban through the procedure as compared to Warfarin.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026