NCT02666742

DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation

SafeTy and Efficacy of Direct Oral Anticoagulant Versus Aspirin for Reduction Of RisK of CErebrovascular Events in Patients Undergoing Ventricular Tachycardia Ablation (STROKE-VT)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Kansas City Heart Rhythm Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Ventricular Tachycardia
• Premature Ventricular Contraction
• Stroke

Interventions

Type	Name	Description
DRUG	DOAC	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.
DRUG	Aspirin	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.

Timeline

• Start date: 2017-02-16
• Primary completion: 2020-05-01
• Completion: 2021-04-30
• First posted: 2016-01-28
• Last updated: 2022-08-22
• Results posted: 2021-09-24

Locations

5 sites across 2 countries: United States, India

Regulatory

• FDA-regulated drug study