Ventricular Tachycardia, Premature Ventricular Contraction, Stroke
Conditions
Keywords
Radiofrequency ablation, anticoagulation, Direct oral anticoagulants, Aspirin, Ventricular arrhythmia
Brief 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.
Interventions
DRUGDOAC
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.
DRUGAspirin
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.
Sponsors
Kansas City Heart Rhythm Research Foundation
Kansas City Heart Rhythm Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Transient Ischemic Attack | 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 | 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 | 24 Hours post ablation | MRI detected asymptomatic cerebrovascular events (ACE) at 24 hours. |
| Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days | 24 Hours to 30 days of post ablation | MRI detected asymptomatic cerebrovascular events (ACE) at 30 days follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Groin Hematoma | Day 30 | A hematoma is a collection of blood outside of a blood vessel. |
| Number of Participants With Retroperitoneal Bleed | Day 30 | Retroperitoneal bleeding occurs when blood enters into space immediately behind the posterior reflection of the abdominal peritoneum. The organs of this space include the esophagus, aorta, inferior vena cava, kidneys, ureters, adrenals, rectum, parts of the duodenum, parts of the pancreas, and parts of the colon. |
| Number of Participants With Acute Procedure Related Complications | Day 30 | The secondary endpoints included procedure-related complications (composite of any vascular complication, pericardial complication, heart block, thromboembolic event excluding stroke or TIA) and in-hospital mortality. |
| Number of Participants With In-hospital Mortality | Day 30 | Death occurring during the hospital stay. |
| Number of Participants With Heart Block | Day 30 | Heart block is a type of heart rhythm disorder (arrhythmia). It is the slowing down or interruption of the electrical signal from the upper chambers of the heart (the atria) to the lower chambers (the ventricles). The electrical signal causes the heart muscle to contract and the heart to beat. |
| Number of Participants With Cardiac Tamponade | Day 30 | Cardiac tamponade is a medical emergency that takes place when abnormal amounts of fluid accumulate in the pericardial sac compressing the heart and leading to a decrease in cardiac output and shock. |
| Number of Participants With Fatal Pulmonary Embolism | Day 30 | A pulmonary embolism is a blood clot in the lung that occurs when a clot in another part of the body (often the leg or arm) moves through the bloodstream and becomes lodged in the blood vessels of the lung. This restricts blood flow to the lungs, lowers oxygen levels in the lungs and increases blood pressure in the pulmonary arteries. |
| Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD) | Day 30 | Heart failure means that the heart isn't pumping as well as it should be. |
Countries
India, United States
Participant flow
Recruitment details
Men and women (with negative urine pregnancy test or non-breastfeeding) aged at least 18 years old were eligible for the study if they underwent radiofrequency ablation (RFA) for VT (secondary to ischemic or nonischemic cardiomyopathy) or PVC's.
Participants by arm
| Arm | Count |
|---|---|
| DOAC Participants will be asked to take approved dose of the drug for stroke Px
DOAC Apixaban is a blood thinning drug, also called an anticoagulant. DOAC is approved by the U.S. Food and Drug Administration (FDA) for stroke prophylaxis and the treatment of deep vein thrombosis and pulmonary embolism, which are blood clots in the veins or lungs. | 123 |
| Aspirin Participants will be asked to take 81 milligrams by mouth once per day.
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. | 123 |
| Total | 246 |
Baseline characteristics
| Characteristic | DOAC | Aspirin | Total |
|---|---|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 12.5 | 58.3 years STANDARD_DEVIATION 14.7 | 59.95 years STANDARD_DEVIATION 13.7438 |
| Anti-arrhythmic drugs | 100 Participants | 90 Participants | 190 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 24 Participants | 19 Participants | 43 Participants |
| Sex: Female, Male Male | 99 Participants | 104 Participants | 203 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 123 | 3 / 123 |
| other Total, other adverse events | 0 / 123 | 0 / 123 |
| serious Total, serious adverse events | 0 / 123 | 0 / 123 |
Outcome results
Primary
Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours
MRI detected asymptomatic cerebrovascular events (ACE) at 24 hours.
Time frame: 24 Hours post ablation
Population: This is a population group undergoing VT or PVC ablation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DOAC | Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours | 15 Participants |
| Aspirin | Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours | 28 Participants |
Primary
Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days
MRI detected asymptomatic cerebrovascular events (ACE) at 30 days follow-up.
Time frame: 24 Hours to 30 days of post ablation
Population: This is a population group undergoing VT or PVC ablation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DOAC | Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days | 8 Participants |
| Aspirin | Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days | 22 Participants |
Primary
Number of Participants With Stroke
Stroke - incidence of ischemic stroke - defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction.
Time frame: First 30 days of post ablation
Population: This is a population group undergoing VT or PVC ablation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DOAC | Number of Participants With Stroke | 0 Participants |
| Aspirin | Number of Participants With Stroke | 8 Participants |
Primary
Number of Participants With Transient Ischemic Attack
Transient ischemic attack(TIA) - defined as a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction.
Time frame: First 30 days of post ablation
Population: this is a population group undergoing VT or premature ventricular contraction (PVC) ablation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DOAC | Number of Participants With Transient Ischemic Attack | 6 participants |
| Aspirin | Number of Participants With Transient Ischemic Attack | 22 participants |
Comparison: Due to lack of precedent robust clinical data, we performed exploratory study to evaluate safety and efficacy of DOAC vs. Aspirin (ASA) in patients undergoing left ventricular arrhythmia (LVA) ablation; therefore, sample size calculation was not undertaken.p-value: 0.001Chi-squared
Secondary
Number of Participants With Acute Procedure Related Complications
The secondary endpoints included procedure-related complications (composite of any vascular complication, pericardial complication, heart block, thromboembolic event excluding stroke or TIA) and in-hospital mortality.
Time frame: Day 30
Population: patients who meet inclusion criteria
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DOAC | Number of Participants With Acute Procedure Related Complications | 15 Participants |
| Aspirin | Number of Participants With Acute Procedure Related Complications | 17 Participants |
Secondary
Number of Participants With Cardiac Tamponade
Cardiac tamponade is a medical emergency that takes place when abnormal amounts of fluid accumulate in the pericardial sac compressing the heart and leading to a decrease in cardiac output and shock.
Time frame: Day 30
Population: Patients who meet inclusion criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DOAC | Number of Participants With Cardiac Tamponade | 4 Participants |
| Aspirin | Number of Participants With Cardiac Tamponade | 3 Participants |
Secondary
Number of Participants With Fatal Pulmonary Embolism
A pulmonary embolism is a blood clot in the lung that occurs when a clot in another part of the body (often the leg or arm) moves through the bloodstream and becomes lodged in the blood vessels of the lung. This restricts blood flow to the lungs, lowers oxygen levels in the lungs and increases blood pressure in the pulmonary arteries.
Time frame: Day 30
Population: Patients who meet inclusion criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DOAC | Number of Participants With Fatal Pulmonary Embolism | 0 Participants |
| Aspirin | Number of Participants With Fatal Pulmonary Embolism | 1 Participants |
Secondary
Number of Participants With Groin Hematoma
A hematoma is a collection of blood outside of a blood vessel.
Time frame: Day 30
Population: Patients who meet inclusion criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DOAC | Number of Participants With Groin Hematoma | 3 Participants |
| Aspirin | Number of Participants With Groin Hematoma | 4 Participants |
Secondary
Number of Participants With Heart Block
Heart block is a type of heart rhythm disorder (arrhythmia). It is the slowing down or interruption of the electrical signal from the upper chambers of the heart (the atria) to the lower chambers (the ventricles). The electrical signal causes the heart muscle to contract and the heart to beat.
Time frame: Day 30
Population: Patients who meet inclusion criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DOAC | Number of Participants With Heart Block | 2 Participants |
| Aspirin | Number of Participants With Heart Block | 3 Participants |
Secondary
Number of Participants With In-hospital Mortality
Death occurring during the hospital stay.
Time frame: Day 30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DOAC | Number of Participants With In-hospital Mortality | 5 Participants |
| Aspirin | Number of Participants With In-hospital Mortality | 3 Participants |
Secondary
Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD)
Heart failure means that the heart isn't pumping as well as it should be.
Time frame: Day 30
Population: Patients who meet inclusion criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DOAC | Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD) | 4 Participants |
| Aspirin | Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD) | 4 Participants |
Secondary
Number of Participants With Retroperitoneal Bleed
Retroperitoneal bleeding occurs when blood enters into space immediately behind the posterior reflection of the abdominal peritoneum. The organs of this space include the esophagus, aorta, inferior vena cava, kidneys, ureters, adrenals, rectum, parts of the duodenum, parts of the pancreas, and parts of the colon.
Time frame: Day 30
Population: Patients who meet inclusion criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DOAC | Number of Participants With Retroperitoneal Bleed | 2 Participants |
| Aspirin | Number of Participants With Retroperitoneal Bleed | 2 Participants |