Ventricular TachycardiaPhase 4STROKE-VTNCT02666742

DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation

A Phase 4 study testing DOAC and Aspirin in people with Ventricular Tachycardia and Premature Ventricular Contraction, run by Kansas City Heart Rhythm Institute at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Ventricular Tachycardia, Premature Ventricular Contraction, Stroke
What is being tested?: DOAC and Aspirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 246 participants
Where: 5 sitesin 2 countries
Study dates: 16 Feb 2017to 30 Apr 2021
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

United States4 sites

TCAI
Austin, Texas, 78701
University of Kansas Medical Center
Kansas City, Kansas, 66160
KCHRF
Overland Park, Kansas, 66221
Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

India1 site

Jayadeva Institute of Medical Sciences
Bengaluru, Karnataka

Other trials in India

About this study

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)

Read the 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.

Conditions: Ventricular Tachycardia, Premature Ventricular Contraction, Stroke
Being tested: DOAC, Aspirin
Keywords: Radiofrequency ablation, anticoagulation, Direct oral anticoagulants, Aspirin, Ventricular arrhythmia
Medical subject headings: Tachycardia, Ventricular, Ventricular Premature Complexes, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DOACDrug
Also called Direct Oral Anti Coagulants, Rivaroxaban, Apixiban, Dabigatran
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.
AspirinDrug
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.

Study groups in NCT02666742
Study group	Role	What they receive
DOAC (Direct Oral Anticoagulant)	Experimental	Participants will be asked to take standard dose approved for stroke prophylaxis Receives: Drug: DOAC
Aspirin	Active comparator	Participants will be asked to take 81 milligrams by mouth once per day. Receives: Drug: Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 Hours to 30 days of post ablation

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 30
Number of Participants With Groin Hematoma
A hematoma is a collection of blood outside of a blood vessel.
Measured: 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.
Measured: 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.
Measured: Day 30
Number of Participants With In-hospital Mortality
Death occurring during the hospital stay.
Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Feb 201730 Apr 2021

First posted28 Jan 2016 (estimated)
Study start16 Feb 2017
Primary completion1 May 2020
Study completion30 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 246 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02666742
Sponsor's protocol ID: STUDY00003241
Other IDs: CV185-415
Acronym: STROKE-VT
Status last verified: Aug 2021
First submitted: 25 Jan 2016
Last updated: 22 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 25673997
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.
PubMed 24813379

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia

All Ventricular Tachycardia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02666742
Acronym / sponsor ID: STROKE-VT / STUDY00003241
Conditions: Ventricular Tachycardia, Premature Ventricular Contraction, Stroke
Keywords: Radiofrequency ablation, anticoagulation, Direct oral anticoagulants, Aspirin, Ventricular arrhythmia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 246 participants (actual)
Lead sponsor: Kansas City Heart Rhythm InstituteUniversity, hospital or other
Collaborators: Kansas City Heart Rhythm Research Foundation
Study start: 16 Feb 2017 (actual)
Primary completion: 1 May 2020 (actual)
Study completion: 30 Apr 2021 (actual)
First posted: 28 Jan 2016 (estimated)
Results: Posted 24 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Participation in this study will last about 30 days.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
DOAC (Direct Oral Anticoagulant)	Experimental	Drug: DOACParticipants will be asked to take standard dose approved for stroke prophylaxis
Aspirin	Active comparator	Drug: AspirinParticipants will be asked to take 81 milligrams by mouth once per day.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DOACAlso: Direct Oral Anti Coagulants, Rivaroxaban, Apixiban, DabigatranDOAC 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.	Drug	DOAC (Direct Oral Anticoagulant)
AspirinAspirin works by reducing substances in the body that cause pain, fever, and inflammation. Aspirin is used to treat pain, and reduce fever or inflammation.	Drug	Aspirin

Primary outcome

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.
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.
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.
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.

8 secondary outcomes

Number of Participants With Acute Procedure Related Complications
Time frame: Day 30
Number of Participants With Cardiac Tamponade
Time frame: Day 30
Number of Participants With Fatal Pulmonary Embolism
Time frame: Day 30
Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD)
Time frame: Day 30
Number of Participants With Groin Hematoma
Time frame: Day 30
Number of Participants With Retroperitoneal Bleed
Time frame: Day 30
Number of Participants With Heart Block
Time frame: Day 30
Number of Participants With In-hospital Mortality
Time frame: Day 30

Results and safety

Results posted to the registry on 24 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Direct Oral Anticoagulant (DOAC)	123	123
Aspirin	123	123

Primary outcome: Number of Participants With Transient Ischemic Attack

Time frame: First 30 days of post ablation. Number. Unit: participants

Measure	DOAC n = 123	Aspirin n = 123
Value	6	22

DOAC vs Aspirin: p = 0.001, Chi-squared

Population analysed: this is a population group undergoing VT or premature ventricular contraction (PVC) ablation

Primary outcome: Number of Participants With Stroke

Time frame: First 30 days of post ablation. Count of participants. Unit: Participants

Measure	DOAC n = 123	Aspirin n = 123
Value	0	8

Population analysed: This is a population group undergoing VT or PVC ablation

Primary outcome: Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours

Time frame: 24 Hours post ablation. Count of participants. Unit: Participants

Measure	DOAC n = 123	Aspirin n = 123
Value	15	28

Population analysed: This is a population group undergoing VT or PVC ablation

Primary outcome: Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days

Time frame: 24 Hours to 30 days of post ablation. Count of participants. Unit: Participants

Measure	DOAC n = 123	Aspirin n = 123
Value	8	22

Population analysed: This is a population group undergoing VT or PVC ablation

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: First 30 days of post ablation. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Apixaban	0 of 123 (0%)	0 of 123 (0%)	5 of 123
Aspirin	0 of 123 (0%)	0 of 123 (0%)	3 of 123

Limitations and caveats (from the sponsor): Our results should be considered in light of several significant limitations. An important limitation was the lack of long-term follow-up and quality-of-life and neurocognitive function information. Another methodological limitation of the outcomes was that the ASA group did not get a loading dose, perhaps the delay in achieving the therapeutic effects in denovo ASA initiation could increase the risk of events.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25673997Cabral 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.
Background: PubMed 24813379Ghanbari 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.
Individual participant dataSharing planned: No

Related trials for Ventricular Tachycardia

Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dhanunjaya Lakkireddy, MD principal investigator

Kansas City Heart Rhythm Research Foundation

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing DOAC and Aspirin in people with Ventricular Tachycardia and Premature Ventricular Contraction, run by Kansas City Heart Rhythm Institute at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Transient Ischemic Attack (time frame: First 30 days of post ablation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02666742, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.