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

Primary Purpose

Ventricular Tachycardia, Premature Ventricular Contraction, Stroke

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
DOAC
Aspirin
Sponsored by
Kansas City Heart Rhythm Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventricular Tachycardia focused on measuring Radiofrequency ablation, anticoagulation, Direct oral anticoagulants, Aspirin, Ventricular arrhythmia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center
  • KCHRF
  • Montefiore Medical Center
  • TCAI
  • Jayadeva Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DOAC (Direct Oral Anticoagulant)

Aspirin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours
MRI detected asymptomatic cerebrovascular events (ACE) at 24 hours.
Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days
MRI detected asymptomatic cerebrovascular events (ACE) at 30 days follow-up.

Secondary Outcome Measures

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.
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.
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.
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.
Number of Participants With Groin Hematoma
A hematoma is a collection of blood outside of a blood vessel.
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.
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.
Number of Participants With In-hospital Mortality
Death occurring during the hospital stay.

Full Information

First Posted
January 25, 2016
Last Updated
August 18, 2022
Sponsor
Kansas City Heart Rhythm Institute
Collaborators
Kansas City Heart Rhythm Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02666742
Brief Title
DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation
Acronym
STROKE-VT
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 16, 2017 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kansas City Heart Rhythm Institute
Collaborators
Kansas City Heart Rhythm Research Foundation

4. Oversight

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
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Premature Ventricular Contraction, Stroke
Keywords
Radiofrequency ablation, anticoagulation, Direct oral anticoagulants, Aspirin, Ventricular arrhythmia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DOAC (Direct Oral Anticoagulant)
Arm Type
Experimental
Arm Description
Participants will be asked to take standard dose approved for stroke prophylaxis
Arm Title
Aspirin
Arm Type
Active Comparator
Arm Description
Participants will be asked to take 81 milligrams by mouth once per day.
Intervention Type
Drug
Intervention Name(s)
DOAC
Other Intervention Name(s)
Direct Oral Anti Coagulants, Rivaroxaban, Apixiban, Dabigatran, Edoxaban
Intervention Description
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
Intervention Name(s)
Aspirin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Transient Ischemic Attack
Description
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
Title
Number of Participants With Stroke
Description
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
Title
Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours
Description
MRI detected asymptomatic cerebrovascular events (ACE) at 24 hours.
Time Frame
24 Hours post ablation
Title
Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days
Description
MRI detected asymptomatic cerebrovascular events (ACE) at 30 days follow-up.
Time Frame
24 Hours to 30 days of post ablation
Secondary Outcome Measure Information:
Title
Number of Participants With Acute Procedure Related Complications
Description
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
Title
Number of Participants With Cardiac Tamponade
Description
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
Title
Number of Participants With Fatal Pulmonary Embolism
Description
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.
Time Frame
Day 30
Title
Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD)
Description
Heart failure means that the heart isn't pumping as well as it should be.
Time Frame
Day 30
Title
Number of Participants With Groin Hematoma
Description
A hematoma is a collection of blood outside of a blood vessel.
Time Frame
Day 30
Title
Number of Participants With Retroperitoneal Bleed
Description
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.
Time Frame
Day 30
Title
Number of Participants With Heart Block
Description
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.
Time Frame
Day 30
Title
Number of Participants With In-hospital Mortality
Description
Death occurring during the hospital stay.
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhanunjaya Lakkireddy, MD
Organizational Affiliation
Kansas City Heart Rhythm Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
KCHRF
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66221
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
TCAI
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
Jayadeva Institute of Medical Sciences
City
Bengaluru
State/Province
Karnataka
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25673997
Citation
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.
Results Reference
background
PubMed Identifier
24813379
Citation
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].
Results Reference
background

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DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation

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