Safety and Efficacy of Post Ablation Apixaban Use for Reduction of the Risk of Cerebrovascular Events in Patients Undergoing Ventricular Tachycardia Radiofrequency Catheter Ablation


The purpose of this study is to learn if taking a drug called Apixaban after an ablation
procedure keeps blood clots from forming and lowers the chance of having a stroke in
patients with ventricular tachycardia (VT).

Eligibility Criteria


Inclusion Criteria:

- Patients undergoing radiofrequency catheter ablation for scar VT which includes VT
secondary to ischemic cardiomyopathy and non-ischemic cardiomyopathy

- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
test within 24 hours prior to the start of study drug

- Women must not be breastfeeding

- WOCBP must agree to follow instructions for method(s) of contraception for the
duration of treatment with Apixaban plus 33 days post-treatment completion

- Males who are sexually active with WOCBP must agree to follow instructions for
method(s) of contraception for the duration of treatment and for a total of 93 days
post-treatment completion

- Participants must agree to the use of one approved method of contraception

Exclusion Criteria:

- History of cerebral vascular accident/transient ischemic attack (CVA/TIA) in last 3
months

- Cardiac surgery or neurosurgery within 3 months of the intended procedure date

- Any active bleeding

- Severe hypersensitivity reaction to ELIQUIS (including drug hypersensitivity, such as
skin rash and allergic reactions)

- Participants cannot have prosthetic heart valves

- History or bleeding and clotting disorders

- Contraindications to Aspirin therapy

- Contraindication to oral anticoagulation

- Patient on an anticoagulant prior to the ablation for other primary indications like
atrial fibrillation (AF), deep vein thrombosis (DVT) or a mechanical valve

- Evidence of intracardiac thrombus

- Patient with Creatinine Clearance of
- Participation in another investigational study related to oral anticoagulation, drug
and/or device intervention

- Claustrophobic patients

- Implantable Cardioverter Defibrillator (ICD) generator placement before the year 2000

- Has an ICD and is pacing dependent without underlying rhythm upon interrogation at
baseline

- Patient has abandoned leads

- Patients who are on p-glycoprotein inducers or inhibitors where the dose of Apixaban
cannot be effectively altered

Principal Investigator

Dhanunjaya Lakkireddy, MD

Study Contact

Donita Atkins, datkins2@kumc.edu, (913) 588-9714

Estimated Completion Date

Friday, December 1, 2017

ClinicalTrials.gov #

NCT02666742
01/27/2016