DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation (STROKE-VT)

K

Kansas City Heart Rhythm Institute

Status and phase

Completed
Phase 4

Conditions

Stroke
Premature Ventricular Contraction
Ventricular Tachycardia

Treatments

Drug: DOAC
Drug: Aspirin

Study type

Interventional

Funder types

Other

Identifiers

NCT02666742
CV185-415 (Other Identifier)
STUDY00003241

Details and patient eligibility

About

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).

Full 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.

Enrollment

246 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

246 participants in 2 patient groups

DOAC (Direct Oral Anticoagulant)
Experimental group
Description:
Participants will be asked to take standard dose approved for stroke prophylaxis
Treatment:
Drug: DOAC
Aspirin
Active Comparator group
Description:
Participants will be asked to take 81 milligrams by mouth once per day.
Treatment:
Drug: Aspirin

Trial documents
1

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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