Patients With Patent Foramen Ovale and Endocardial Device Leads on Apixaban for Prevention of Paradoxical Emboli

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

May 31, 2015

Primary Completion Date

January 31, 2020

Study Completion Date

January 31, 2020

Conditions
Patent Foramen OvaleCardiac Implantable Electronic Device
Interventions
DRUG

Apixaban

Patients who meet the study eligibility criteria and consent for enrollment will be randomized in a 1:1 ratio to intervention with apixaban or control group with placebo. The randomization will be performed by a computer generated block randomization protocol. Randomization will be stratified according to pre-existing CIED (≥6 months) vs. new implantation (\<6 months from date of implant), in order to ensure at least 25% of patients have longstanding lead placement.

DRUG

Placebo

Patients who meet the study eligibility criteria and consent for enrollment will be randomized in a 1:1 ratio to intervention with apixaban or control group with placebo. The randomization will be performed by a computer generated block randomization protocol. Randomization will be stratified according to pre-existing CIED (≥6 months) vs. new implantation (\<6 months from date of implant), in order to ensure at least 25% of patients have longstanding lead placement.

Trial Locations (1)

55905

Mayo Clinic in Rochester, Rochester

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Mayo Clinic

OTHER

NCT02378623 - Patients With Patent Foramen Ovale and Endocardial Device Leads on Apixaban for Prevention of Paradoxical Emboli | Biotech Hunter | Biotech Hunter