DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation

• Status: Completed
• Trial end date: 2021-04-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dhanunjaya Lakkireddy, MD, FACC; Kansas City Heart Rhythm Institute
• Collaborators: Bristol-Myers Squibb; Kansas City Heart Rhythm Research Foundation
• Treatments: Anticoagulants; Apixaban; Aspirin; Coagulants; Dabigatran; Edoxaban; Rivaroxaban

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