DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation (STROKE-VT)

SafeTy and Efficacy of Direct Oral Anticoagulant Versus Aspirin for Reduction Of RisK of CErebrovascular Events in Patients Undergoing Ventricular Tachycardia Ablation (STROKE-VT)

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).

Study Overview

• Status: Completed
• Conditions: Stroke; Ventricular Tachycardia; Premature Ventricular Contraction
• Intervention / Treatment: Drug: DOAC; Drug: Aspirin

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.

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bengaluru, Karnataka, India
      • Jayadeva Institute of Medical Sciences
• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
    • Overland Park, Kansas, United States, 66221
      • KCHRF
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Texas
    • Austin, Texas, United States, 78701
      • TCAI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DOAC (Direct Oral Anticoagulant); Participants will be asked to take standard dose approved for stroke prophylaxis	Drug: 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.; Other Names: Dabigatran; Edoxaban; Rivaroxaban; Direct Oral Anti Coagulants; Apixiban
Active Comparator: Aspirin; Participants will be asked to take 81 milligrams by mouth once per day.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	24 Hours to 30 days of post ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day 30
Number of Participants With Fatal Pulmonary Embolism	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.	Day 30
Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD)	Heart failure means that the heart isn't pumping as well as it should be.	Day 30
Number of Participants With Groin Hematoma	A hematoma is a collection of blood outside of a blood vessel.	Day 30
Number of Participants With Retroperitoneal Bleed	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.	Day 30
Number of Participants With Heart Block	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.	Day 30
Number of Participants With In-hospital Mortality	Death occurring during the hospital stay.	Day 30

Collaborators and Investigators

• Sponsor: Kansas City Heart Rhythm Institute
• Collaborators: Kansas City Heart Rhythm Research Foundation
• Investigators: Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Research Foundation

Publications and helpful links

General Publications

• Cabral KP, Ansell JE. The role of factor Xa inhibitors in venous thromboembolism treatment. Vasc Health Risk Manag. 2015 Jan 30;11:117-23. doi: 10.2147/VHRM.S39726. eCollection 2015.
• Ghanbari H, Baser K, Jongnarangsin K, Chugh A, Nallamothu BK, Gillespie BW, Baser HD, Suwanagool A, Crawford T, Latchamsetty R, Good E, Pelosi F Jr, Bogun F, Morady F, Oral H. Mortality and cerebrovascular events after radiofrequency catheter ablation of atrial fibrillation. Heart Rhythm. 2014 Sep;11(9):1503-11. doi: 10.1016/j.hrthm.2014.05.003. Epub 2014 May 6. Erratum In: Heart Rhythm. 2015 Jan;12(1):253. Swangasool, Arisara [corrected to Suwanagool, Arisara].

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2017
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 28, 2016

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Aspirin; anticoagulation; Ventricular arrhythmia; Radiofrequency ablation; Direct oral anticoagulants
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Cardiac Complexes, Premature; Stroke; Tachycardia; Tachycardia, Ventricular; Ventricular Premature Complexes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Aspirin; Rivaroxaban; Dabigatran; Edoxaban; Anticoagulants; Coagulants
• Other Study ID Numbers: STUDY00003241; CV185-415 (Other Identifier: KCHRF)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No