SafeTy and Efficacy of Direct Oral Anticoagulant Versus Aspirin for Reduction Of RisK of CErebrovascular Events in Patients Undergoing Ventricular Tachycardia Ablation (STROKE-VT)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 5
- 主要终点
- Number of Participants With Transient Ischemic Attack
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
DOAC (Direct Oral Anticoagulant)
Participants will be asked to take standard dose approved for stroke prophylaxis
干预措施: DOAC (Drug)
Aspirin
Participants will be asked to take 81 milligrams by mouth once per day.
干预措施: Aspirin (Drug)
结局指标
主要结局
Number of Participants With Transient Ischemic Attack
时间窗: First 30 days of post ablation
Transient ischemic attack(TIA) - defined as a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction.
Number of Participants With Stroke
时间窗: First 30 days of post ablation
Stroke - incidence of ischemic stroke - defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction.
Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours
时间窗: 24 Hours post ablation
MRI detected asymptomatic cerebrovascular events (ACE) at 24 hours.
Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days
时间窗: 24 Hours to 30 days of post ablation
MRI detected asymptomatic cerebrovascular events (ACE) at 30 days follow-up.
次要结局
- Number of Participants With Cardiac Tamponade(Day 30)
- Number of Participants With Fatal Pulmonary Embolism(Day 30)
- Number of Participants With In-hospital Mortality(Day 30)
- Number of Participants With Acute Procedure Related Complications(Day 30)
- Number of Participants With Heart Block(Day 30)
- Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD)(Day 30)
- Number of Participants With Groin Hematoma(Day 30)
- Number of Participants With Retroperitoneal Bleed(Day 30)