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

Mayo Clinic1 site in 1 countryFebruary 2016

ConditionsAtrial Fibrillation

InterventionsApixaban Warfarin

DrugsApixaban Warfarin

Overview

Phase: Phase 2
Intervention: Apixaban
Conditions: Atrial Fibrillation
Sponsor: Mayo Clinic
Locations: 1
Primary Endpoint: decrease in the hemoglobin level of 2 g per deciliter or more
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

March 2017

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Yong-Mei Cha

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Apixaban

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

Intervention: Apixaban

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.

Intervention: Warfarin