DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-16

Study Completion Date

2021-04-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Ventricular Tachycardia Premature Ventricular Contraction Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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DOAC (Direct Oral Anticoagulant)

Participants will be asked to take standard dose approved for stroke prophylaxis

Group Type EXPERIMENTAL

DOAC

Intervention Type DRUG

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.

Aspirin

Participants will be asked to take 81 milligrams by mouth once per day.

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

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.

Interventions

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DOAC

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.

Intervention Type DRUG

Aspirin

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.

Intervention Type DRUG

Other Intervention Names

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Direct Oral Anti Coagulants Rivaroxaban Apixiban Dabigatran Edoxaban

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No