DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation

Kansas City Heart Rhythm Institute246 enrolled

Overview

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).

Ventricular tachycardia (VT) or fast heart rhythm is a condition where the lower chambers (ventricles) of the heart beat too fast. This condition can be life threatening because these ventricles are the main pumping chambers of the heart. The fast heartbeat is caused by electrical impulses that travel incorrectly in your heart. One way to treat VT is to have a catheter ablation procedure. A catheter ablation is a procedure that creates scar tissue in the heart to interrupt the electrical impulses that create irregular heart rhythms. It is possible that the ablation procedure might cause a blood clot to form. The blood clot can stop blood flow to the brain and cause a stroke. When blood flow is interrupted to a certain part of the brain, that part does not receive enough oxygen. As a result of the stroke the affected areas of the brain are unable to function normally. Direct oral anticoagulant (DOAC) is a blood thinning drug, also called an anticoagulant. It interferes with the body's natural blood clotting ability by inactivating a specific enzyme that the body needs to form blood clots. Participation in this study will last about 30 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

246

Conditions

Ventricular Tachycardia Premature Ventricular Contraction Stroke

Interventions

DOACDRUG

DOAC is a blood thinning drug, also called direct oral anticoagulant. These group of drugs are approved by the U.S. Food and Drug Administration (FDA) for the treatment of stroke prophylaxis in atrial fibrillation and deep vein thrombosis and pulmonary embolism, which are blood clots in the veins or lungs.

AspirinDRUG

Aspirin works by reducing substances in the body that cause pain, fever, and inflammation. Aspirin is used to treat pain, and reduce fever or inflammation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (5)

University of Kansas Medical Center

Kansas City, Kansas, United States

KCHRF

Overland Park, Kansas, United States

Montefiore Medical Center

The Bronx, New York, United States

TCAI

Austin, Texas, United States

Outcomes

Primary Outcomes

Number of Participants With Transient Ischemic Attack

Transient ischemic attack(TIA) - defined as a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction.

Time frame: First 30 days of post ablation

Number of Participants With Stroke

Stroke - incidence of ischemic stroke - defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction.

Time frame: First 30 days of post ablation

Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours

MRI detected asymptomatic cerebrovascular events (ACE) at 24 hours.

Time frame: 24 Hours post ablation

Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days

MRI detected asymptomatic cerebrovascular events (ACE) at 30 days follow-up.

Time frame: 24 Hours to 30 days of post ablation

Secondary Outcomes

Number of Participants With Acute Procedure Related Complications

The secondary endpoints included procedure-related complications (composite of any vascular complication, pericardial complication, heart block, thromboembolic event excluding stroke or TIA) and in-hospital mortality.

Time frame: Day 30

Number of Participants With Cardiac Tamponade

Cardiac tamponade is a medical emergency that takes place when abnormal amounts of fluid accumulate in the pericardial sac compressing the heart and leading to a decrease in cardiac output and shock.

Time frame: Day 30

Data from ClinicalTrials.gov

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