Clinical trial NCT02666742: DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ventricular Tachycardia
Premature Ventricular Contraction
Stroke
Keywords: Radiofrequency ablation
anticoagulation
Direct oral anticoagulants
Aspirin
Ventricular arrhythmia
Lead sponsor: Kansas City Heart Rhythm Institute
Sponsor class: OTHER
Collaborators: name: Kansas City Heart Rhythm Research Foundation
First posted: 2016-01-28
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants With Transient Ischemic Attack
timeFrame: First 30 days of post ablation
measure: Number of Participants With Stroke
timeFrame: First 30 days of post ablation
measure: Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours
timeFrame: 24 Hours post ablation
measure: Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days
timeFrame: 24 Hours to 30 days of post ablation
Secondary outcomes:
measure: Number of Participants With Acute Procedure Related Complications
timeFrame: Day 30
measure: Number of Participants With Cardiac Tamponade
timeFrame: Day 30
measure: Number of Participants With Fatal Pulmonary Embolism
timeFrame: Day 30
measure: Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD)
timeFrame: Day 30
measure: Number of Participants With Groin Hematoma
timeFrame: Day 30
measure: Number of Participants With Retroperitoneal Bleed
timeFrame: Day 30
measure: Number of Participants With Heart Block
timeFrame: Day 30
measure: Number of Participants With In-hospital Mortality
timeFrame: Day 30
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Overland Park
country: United States
facility: KCHRF
state: Kansas
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Austin
country: United States
facility: TCAI
state: Texas
city: Bengaluru
country: India
facility: Jayadeva Institute of Medical Sciences
state: Karnataka
Study officials:
affiliation: Kansas City Heart Rhythm Research Foundation
name: Dhanunjaya Lakkireddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.