DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation

Stroke Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02666742
• Other study ID #: STUDY00003241
• Secondary ID: CV185-415
• Status: Completed
• Phase: Phase 4
• Start date: February 16, 2017
• Est. completion date: April 30, 2021

Study information

• Verified date: August 2021
• Source: Kansas City Heart Rhythm Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: April 30, 2021
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Ventricular Contraction
• Stroke
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Premature Complexes
• Ventricular Tachycardia

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	Jayadeva Institute of Medical Sciences	Bengaluru	Karnataka
United States	TCAI	Austin	Texas
United States	Montefiore Medical Center	Bronx	New York
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	KCHRF	Overland Park	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Institute	Kansas City Heart Rhythm Research Foundation

Countries where clinical trial is conducted

United States,  India, 

References & Publications (2)

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. Review. — View 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]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours	MRI detected asymptomatic cerebrovascular events (ACE) at 24 hours.	24 Hours post ablation
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants With Groin Hematoma	A hematoma is a collection of blood outside of a blood vessel.	Day 30
Secondary	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
Secondary	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
Secondary	Number of Participants With In-hospital Mortality	Death occurring during the hospital stay.	Day 30