NCT02450682

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_2 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

January 18, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

May 19, 2015

Last Update Submit

January 14, 2016

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • decrease in the hemoglobin level of 2 g per deciliter or more

    Assess the risk of major bleeding when continuing apixaban through the procedure as compared to Warfarin.

    2 months

Study Arms (2)

Apixaban

ACTIVE COMPARATOR

30 participants prescribed Apixaban 3-14 days before and 28 days after CIED procedure.

Drug: Apixaban

Warfarin

OTHER

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

Interventions

ApixabanDRUG

Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change

Also known as: Eliquis
Apixaban
WarfarinDRUG

Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change

Also known as: Coumadin
Warfarin

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patient is critically ill, or in unstable condition
  • Patient is at high risk for bleeding, HAS-BLED score ≥ 3
  • Patient is required to take dual antiplatelet agents in addition to anticoagulant drug. (e.g. recent cardiac stent placement)
  • Patients have mechanical cardiac valve or another condition other than NVAF that requires chronic anticoagulation
  • Women of childbearing potential with positive pregnant test
  • Bilirubin \>2x upper limit of normal, in association with AST/ALT/ALP \>3x upper limit normal
  • Allergy to apixaban and warfarin
  • Subjects requiring taking strong dual inhibitors of CYP3A4 and P-gp who already meet the criteria to take 2.5 mg apixaban
  • Subjects requiring taking strong dual inducers of CYP3A4 and P-gp (.e.g., rifampin, carbamazepine, phenytoin, St. John's wort)
  • Patients who take any investigational drugs within 30 days of enrolling in study.
  • Prisoners or subjects who are involuntarily incarcerated.
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

apixabanWarfarin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Yong-Mei Cha, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Samuel Asirvatham, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 21, 2015

Study Start

February 1, 2016

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

January 18, 2016

Record last verified: 2016-01

Locations

US(1)