DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation
Condition: Ventricular Tachycardia; Premature Ventricular Contraction; Stroke
MeSH terms: Stroke; Tachycardia; Tachycardia, Ventricular; Ventricular Premature Complexes
Intervention: DOAC; Aspirin
Intervention description: 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 works by reducing substances in the body that cause pain, fever, and inflammation. Aspirin is used to treat pain, and reduce fever or inflammation.
Intervention MeSH terms: Aspirin; Rivaroxaban; Edoxaban; Dabigatran; Anticoagulants; Coagulants
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 246.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Radiofrequency ablation; anticoagulation; Direct oral anticoagulants; Aspirin; Ventricular arrhythmia

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).
    

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