DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation

Completed · Phase 4

Conditions studied: Ventricular Tachycardia, Premature Ventricular Contraction, Stroke

In brief

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).

Key facts

Study ID

NCT02666742

Run by

Kansas City Heart Rhythm Institute

People needed

246

Starts

2017-02-16

Expected to finish

2021-04-30

Last updated by the study team

2022-08-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• Patient has abandoned leads
• Patients who are on p-glycoprotein inducers or inhibitors where the dose of Apixaban cannot be effectively altered

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States
• KCHRF — Overland Park, Kansas, United States
• Montefiore Medical Center — The Bronx, New York, United States
• TCAI — Austin, Texas, United States
• Jayadeva Institute of Medical Sciences — Bengaluru, Karnataka, India

Full record on ClinicalTrials.gov

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