DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation

Phase 4

Completed

• Conditions: Ventricular Tachycardia; Premature Ventricular Contraction; Stroke
• Interventions: Drug: Aspirin; Drug: DOAC

• Registration Number: NCT02666742
• Lead Sponsor: Kansas City Heart Rhythm Institute

Brief 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).

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-01-25
• Study First Posted: 2016-01-28
• Study Start: 2017-02-16
• Primary Completion: 2020-05-01
• Study Completion: 2021-04-30
• Results First Submitted: 2021-07-30
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-30
• Results First Posted: 2021-09-24
• Last Update Submitted: 2022-08-18
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin	Aspirin	Participants will be asked to take 81 milligrams by mouth once per day.
DOAC (Direct Oral Anticoagulant)	DOAC	Participants will be asked to take standard dose approved for stroke prophylaxis

Primary Outcome Measures

Name	Time	Method
Number of Participants With Transient Ischemic Attack	First 30 days of post ablation	Transient ischemic attack(TIA) - defined as a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction.
Number of Participants With Stroke	First 30 days of post ablation	Stroke - incidence of ischemic stroke - defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction.
Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours	24 Hours post ablation	MRI detected asymptomatic cerebrovascular events (ACE) at 24 hours.
Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days	24 Hours to 30 days of post ablation	MRI detected asymptomatic cerebrovascular events (ACE) at 30 days follow-up.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Cardiac Tamponade	Day 30	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.
Number of Participants With Fatal Pulmonary Embolism	Day 30	A pulmonary embolism is a blood clot in the lung that occurs when a clot in another part of the body (often the leg or arm) moves through the bloodstream and becomes lodged in the blood vessels of the lung. This restricts blood flow to the lungs, lowers oxygen levels in the lungs and increases blood pressure in the pulmonary arteries.
Number of Participants With In-hospital Mortality	Day 30	Death occurring during the hospital stay.
Number of Participants With Acute Procedure Related Complications	Day 30	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.
Number of Participants With Heart Block	Day 30	Heart block is a type of heart rhythm disorder (arrhythmia). It is the slowing down or interruption of the electrical signal from the upper chambers of the heart (the atria) to the lower chambers (the ventricles). The electrical signal causes the heart muscle to contract and the heart to beat.
Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD)	Day 30	Heart failure means that the heart isn't pumping as well as it should be.
Number of Participants With Groin Hematoma	Day 30	A hematoma is a collection of blood outside of a blood vessel.
Number of Participants With Retroperitoneal Bleed	Day 30	Retroperitoneal bleeding occurs when blood enters into space immediately behind the posterior reflection of the abdominal peritoneum. The organs of this space include the esophagus, aorta, inferior vena cava, kidneys, ureters, adrenals, rectum, parts of the duodenum, parts of the pancreas, and parts of the colon.

Trial Locations

Locations (5)

KCHRF; 🇺🇸 Overland Park, Kansas, United States

TCAI; 🇺🇸 Austin, Texas, United States

Jayadeva Institute of Medical Sciences; 🇮🇳 Bengaluru, Karnataka, India

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States