DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation

NCT02666742 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: STUDY00003241CV185-415
• Study Type: interventional
• Target: 246
• Locations: 2 countries
• Sites: 5

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).

Conditions

Ventricular Tachycardia; Premature Ventricular Contraction; Stroke

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours

  MRI detected asymptomatic cerebrovascular events (ACE) at 24 hours.

  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.

  24 Hours to 30 days of post ablation

Secondary Outcomes (8)

• Number of Participants With Acute Procedure Related Complications

  Day 30

• Number of Participants With Cardiac Tamponade

  Day 30

• Number of Participants With Fatal Pulmonary Embolism

  Day 30

• Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD)

  Day 30

• Number of Participants With Groin Hematoma

  Day 30

Study Arms (2)

DOAC (Direct Oral Anticoagulant)

EXPERIMENTAL

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

Drug: DOAC

Aspirin

ACTIVE COMPARATOR

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

Drug: Aspirin

Interventions

DOAC DRUG

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.

Also known as: Direct Oral Anti Coagulants, Rivaroxaban, Apixiban, Dabigatran, Edoxaban

DOAC (Direct Oral Anticoagulant)

Aspirin DRUG

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.

Aspirin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kansas City Heart Rhythm Institute: lead
• Kansas City Heart Rhythm Research Foundation: collaborator

Study Sites (5)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

KCHRF

Overland Park, Kansas, 66221, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

TCAI

Austin, Texas, 78701, United States

Location

Jayadeva Institute of Medical Sciences

Bengaluru, Karnataka, India

Location

Related 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.

  PMID: 25673997 BACKGROUND

• 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.

  PMID: 24813379 BACKGROUND

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Premature Complexes; Stroke

Interventions

Rivaroxaban; Dabigatran; edoxaban; Aspirin

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Complexes, Premature; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

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.

Results Point of Contact

• Title: Donita Atkins
• Organization: Kansas City Heart Rhythm Institute

Donita.Atkins@hcahealthcare.com

913-253-3064

Study Officials

• Dhanunjaya Lakkireddy, MD

  Kansas City Heart Rhythm Research Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: January 28, 2016
• Study Start: February 16, 2017
• Primary Completion: May 1, 2020
• Study Completion: April 30, 2021
• Last Updated: August 22, 2022
• Results First Posted: September 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); IN (1)