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

January 14, 2016 updated by: Yong-Mei Cha, Mayo Clinic

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Eliquis
Other: 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 Names:
  • Coumadin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Yong-Mei Cha, MD, Mayo Clinic
  • Principal Investigator: Samuel Asirvatham, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

May 20, 2015

First Posted (Estimate)

May 21, 2015

Study Record Updates

Last Update Posted (Estimate)

January 18, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-005395

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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