A Phase 4 interventional study of DOAC and Aspirin in Ventricular Tachycardia, Premature Ventricular Contraction and Stroke, sponsored by Kansas City Heart Rhythm Institute. Completed at 5 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-22.
Sponsored by Kansas City Heart Rhythm Institute · Phase 4, Interventional, and Prevention
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).
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 246 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Kansas City Heart Rhythm Institute is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be asked to take standard dose approved for stroke prophylaxis
Drug: DOAC
Participants will be asked to take 81 milligrams by mouth once per day.
Drug: Aspirin
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.
Also known as: Direct Oral Anti Coagulants, Rivaroxaban, Apixiban, Dabigatran, Edoxaban
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.
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
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
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
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
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
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
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
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
Number of Participants With Groin Hematoma
A hematoma is a collection of blood outside of a blood vessel.
Time frame: Day 30
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
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
Number of Participants With In-hospital Mortality
Death occurring during the hospital stay.
Time frame: Day 30
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.
| Milestone | Direct Oral Anticoagulant (DOAC) | Aspirin |
|---|---|---|
| Started | 123 | 123 |
| Completed | 123 | 123 |
| Not completed | 0 | 0 |
Transient ischemic attack(TIA) - defined as a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction.
| participants | DOAC | Aspirin |
|---|---|---|
| Number of Participants With Transient Ischemic Attack | 6 | 22 |
Stroke - incidence of ischemic stroke - defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction.
| Participants | DOAC | Aspirin |
|---|---|---|
| Number of Participants With Stroke | 0 | 8 |
MRI detected asymptomatic cerebrovascular events (ACE) at 24 hours.
| Participants | DOAC | Aspirin |
|---|---|---|
| Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours | 15 | 28 |
MRI detected asymptomatic cerebrovascular events (ACE) at 30 days follow-up.
| Participants | DOAC | Aspirin |
|---|---|---|
| Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days | 8 | 22 |
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.
| Participants | DOAC | Aspirin |
|---|---|---|
| Number of Participants With Acute Procedure Related Complications | 15 | 17 |
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.
| Participants | DOAC | Aspirin |
|---|---|---|
| Number of Participants With Cardiac Tamponade | 4 | 3 |
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.
| Participants | DOAC | Aspirin |
|---|---|---|
| Number of Participants With Fatal Pulmonary Embolism | 0 | 1 |
Heart failure means that the heart isn't pumping as well as it should be.
| Participants | DOAC | Aspirin |
|---|---|---|
| Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD) | 4 | 4 |
A hematoma is a collection of blood outside of a blood vessel.
| Participants | DOAC | Aspirin |
|---|---|---|
| Number of Participants With Groin Hematoma | 3 | 4 |
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.
| Participants | DOAC | Aspirin |
|---|---|---|
| Number of Participants With Retroperitoneal Bleed | 2 | 2 |
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.
| Participants | DOAC | Aspirin |
|---|---|---|
| Number of Participants With Heart Block | 2 | 3 |
Death occurring during the hospital stay.
| Participants | DOAC | Aspirin |
|---|---|---|
| Number of Participants With In-hospital Mortality | 5 | 3 |
Collected over First 30 days of post ablation. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Apixaban | 5/123 (4.1%) | 0/123 (0%) | 0/123 (0%) |
| Aspirin | 3/123 (2.4%) | 0/123 (0%) | 0/123 (0%) |
Patients undergoing VT or PVC ablation are enrolled into the study. Baseline characteristics of patients including demographics, comorbidities, cardiac function etc were collected and analyzed
| Age, Continuous(years) | DOAC | Aspirin | Total |
|---|---|---|---|
| Mean | 61.6 ± 12.5 | 58.3 ± 14.7 | 59.95 ± 13.7438 |
| Sex: Female, Male(Participants) | DOAC | Aspirin | Total |
|---|---|---|---|
| Female | 24 | 19 | 43 |
| Male | 99 | 104 | 203 |
| Race and Ethnicity Not Collected(Participants) | DOAC | Aspirin | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Anti-arrhythmic drugs(Participants) | DOAC | Aspirin | Total |
|---|---|---|---|
| Count of participants | 100 | 90 | 190 |
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Kansas City Heart Rhythm Institute