Apixaban in Patients Who Undergo CIED Procedure- Randomized Pilot Study

Phase 2

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Drug: Apixaban; Drug: Warfarin

• Registration Number: NCT02450682
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-21
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-01-18
• Study Start: 2016-02
• Primary Completion: 2017-01
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apixaban	Apixaban	30 participants prescribed Apixaban 3-14 days before and 28 days after CIED procedure.
Warfarin	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.

Primary Outcome Measures

Name	Time	Method
decrease in the hemoglobin level of 2 g per deciliter or more	2 months	Assess the risk of major bleeding when continuing apixaban through the procedure as compared to Warfarin.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States