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

• ClinicalTrials.gov Identifier: NCT02666742
• Recruitment Status: Completed
• First Posted: January 28, 2016
• Results First Posted: September 24, 2021
• Last Update Posted: August 22, 2022
• Sponsor: Kansas City Heart Rhythm Institute
• Collaborator: Kansas City Heart Rhythm Research Foundation
• Information provided by (Responsible Party): Kansas City Heart Rhythm Institute

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Ventricular Tachycardia; Premature Ventricular Contraction; Stroke	Drug: DOAC; Drug: Aspirin	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 246 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: SafeTy and Efficacy of Direct Oral Anticoagulant Versus Aspirin for Reduction Of RisK of CErebrovascular Events in Patients Undergoing Ventricular Tachycardia Ablation (STROKE-VT)
• Actual Study Start Date: February 16, 2017
• Actual Primary Completion Date: May 1, 2020
• Actual Study Completion Date: April 30, 2021

Arms and Interventions

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: Direct Oral Anti Coagulants; Rivaroxaban; Apixiban; Dabigatran; Edoxaban
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.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Transient Ischemic Attack [ Time Frame: 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.
2. Number of Participants With Stroke [ Time Frame: 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.
3. Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours [ Time Frame: 24 Hours post ablation ]
   MRI detected asymptomatic cerebrovascular events (ACE) at 24 hours.
4. Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days [ Time Frame: 24 Hours to 30 days of post ablation ]
   MRI detected asymptomatic cerebrovascular events (ACE) at 30 days follow-up.

Secondary Outcome Measures :

1. Number of Participants With Acute Procedure Related Complications [ Time Frame: 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.
2. Number of Participants With Cardiac Tamponade [ Time Frame: 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.
3. Number of Participants With Fatal Pulmonary Embolism [ Time Frame: 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.
4. Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD) [ Time Frame: Day 30 ]
   Heart failure means that the heart isn't pumping as well as it should be.
5. Number of Participants With Groin Hematoma [ Time Frame: Day 30 ]
   A hematoma is a collection of blood outside of a blood vessel.
6. Number of Participants With Retroperitoneal Bleed [ Time Frame: 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.
7. Number of Participants With Heart Block [ Time Frame: 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.
8. Number of Participants With In-hospital Mortality [ Time Frame: Day 30 ]
   Death occurring during the hospital stay.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

KCHRF

Overland Park, Kansas, United States, 66221

United States, New York

Montefiore Medical Center

Bronx, New York, United States, 10467

United States, Texas

TCAI

Austin, Texas, United States, 78701

India

Jayadeva Institute of Medical Sciences

Bengaluru, Karnataka, India

Sponsors and Collaborators

Kansas City Heart Rhythm Institute

Kansas City Heart Rhythm Research Foundation

Investigators

• Principal Investigator: Dhanunjaya Lakkireddy, MD; Kansas City Heart Rhythm Research Foundation

  Study Documents (Full-Text)

Documents provided by Kansas City Heart Rhythm Institute:

Study Protocol and Statistical Analysis Plan  [PDF] October 1, 2018

More Information

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].

• Responsible Party: Kansas City Heart Rhythm Institute
• ClinicalTrials.gov Identifier: NCT02666742
• Other Study ID Numbers: STUDY00003241; CV185-415 ( Other Identifier: KCHRF )
• First Posted: January 28, 2016
• Results First Posted: September 24, 2021
• Last Update Posted: August 22, 2022
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Kansas City Heart Rhythm Institute:

Radiofrequency ablation; anticoagulation; Direct oral anticoagulants; Aspirin; Ventricular arrhythmia

Additional relevant MeSH terms:

Stroke; Tachycardia; Tachycardia, Ventricular; Ventricular Premature Complexes; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiac Conduction System Disease; Pathologic Processes; Cardiac Complexes, Premature; Aspirin; Rivaroxaban; Edoxaban; Dabigatran; Anticoagulants; Coagulants; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents