Overview

DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation

Status:
Completed
Trial end date:
2021-04-30
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to learn if taking a drug called direct oral anticoagulant after an ablation procedure keeps blood clots from forming and lowers the chance of having a stroke in patients with ventricular tachycardia or arrhythmia (VT).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dhanunjaya Lakkireddy, MD, FACC
Kansas City Heart Rhythm Institute
Collaborators:
Bristol-Myers Squibb
Kansas City Heart Rhythm Research Foundation
Treatments:
Anticoagulants
Apixaban
Aspirin
Coagulants
Dabigatran
Edoxaban
Rivaroxaban
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 < 30 cc/min

- 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