Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CV185-415 | Other Identifier | KCHRF |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kansas City Heart Rhythm Research Foundation | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DOAC (Direct Oral Anticoagulant) | Experimental | Participants will be asked to take standard dose approved for stroke prophylaxis |
|
| Aspirin | Active Comparator | Participants will be asked to take 81 milligrams by mouth once per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DOAC | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 24 Hours to 30 days of post ablation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 30 |
| Number of Participants With Cardiac Tamponade |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dhanunjaya Lakkireddy, MD | Kansas City Heart Rhythm Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States | ||
| KCHRF |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25673997 | Background | Cabral KP, Ansell JE. The role of factor Xa inhibitors in venous thromboembolism treatment. Vasc Health Risk Manag. 2015 Jan 30;11:117-23. doi: 10.2147/VHRM.S39726. eCollection 2015. | |
| 24813379 | Background | Ghanbari H, Baser K, Jongnarangsin K, Chugh A, Nallamothu BK, Gillespie BW, Baser HD, Suwanagool A, Crawford T, Latchamsetty R, Good E, Pelosi F Jr, Bogun F, Morady F, Oral H. Mortality and cerebrovascular events after radiofrequency catheter ablation of atrial fibrillation. Heart Rhythm. 2014 Sep;11(9):1503-11. doi: 10.1016/j.hrthm.2014.05.003. Epub 2014 May 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Direct Oral Anticoagulant (DOAC) | Participants will be asked to take a DOAC (Rivaroxaban/Apixiban/Dabigatran/Edoxaban) dose that is approved for stroke prophylaxis for 30 days post ablation DOAC: DOAC is a blood thinning drug, also called an anticoagulant. DOAC is approved by the U.S. Food and Drug Administration (FDA) for the prophylaxis of stroke in atrial fibrillation patients and treatment of deep vein thrombosis and pulmonary embolism, which are blood clots in the veins or lungs. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | this is a population group undergoing VT or premature ventricular contraction (PVC) ablation | Posted | Number | participants | First 30 days of post ablation |
|
First 30 days of post ablation
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Apixaban | Participants will be asked to take 5 milligrams by mouth twice per day. Apixaban: Apixaban is a blood thinning drug, also called an anticoagulant. Apixaban is approved by the U.S. Food and Drug Administration (FDA) for the treatment of deep vein thrombosis and pulmonary embolism, which are blood clots in the veins or lungs. |
Not provided
Not provided
Our results should be considered in light of several significant limitations. An important limitation was the lack of long-term follow-up and quality-of-life and neurocognitive function information. Another methodological limitation of the outcomes was that the ASA group did not get a loading dose, perhaps the delay in achieving the therapeutic effects in denovo ASA initiation could increase the risk of events.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donita Atkins | Kansas City Heart Rhythm Institute | 913-253-3064 | Donita.Atkins@hcahealthcare.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2018 | Jul 30, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D018879 | Ventricular Premature Complexes |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D000069604 | Dabigatran |
| C552171 | edoxaban |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Aspirin | Drug | 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. |
|
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. |
| 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. | 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. | Day 30 |
| Number of Participants With Groin Hematoma | A hematoma is a collection of blood outside of a blood vessel. | 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. | 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. | Day 30 |
| Number of Participants With In-hospital Mortality | Death occurring during the hospital stay. | Day 30 |
| Overland Park |
| Kansas |
| 66221 |
| United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| TCAI | Austin | Texas | 78701 | United States |
| Jayadeva Institute of Medical Sciences | Bengaluru | Karnataka | India |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Anti-arrhythmic drugs | Count of Participants | 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. | This is a population group undergoing VT or PVC ablation | Posted | Count of Participants | Participants | First 30 days of post ablation |
|
|
|
| Primary | Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours | MRI detected asymptomatic cerebrovascular events (ACE) at 24 hours. | This is a population group undergoing VT or PVC ablation | Posted | Count of Participants | Participants | 24 Hours post ablation |
|
|
|
| Primary | Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days | MRI detected asymptomatic cerebrovascular events (ACE) at 30 days follow-up. | This is a population group undergoing VT or PVC ablation | Posted | Count of Participants | Participants | 24 Hours to 30 days of post ablation |
|
|
|
| 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. | patients who meet inclusion criteria | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| 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. | Patients who meet inclusion criteria. | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| 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. | Patients who meet inclusion criteria. | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| 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. | Patients who meet inclusion criteria. | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| Secondary | Number of Participants With Groin Hematoma | A hematoma is a collection of blood outside of a blood vessel. | Patients who meet inclusion criteria. | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| 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. | Patients who meet inclusion criteria. | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| 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. | Patients who meet inclusion criteria. | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| Secondary | Number of Participants With In-hospital Mortality | Death occurring during the hospital stay. | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| 5 |
| 123 |
| 0 |
| 123 |
| 0 |
| 123 |
| EG001 | 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. | 3 | 123 | 0 | 123 | 0 | 123 |
Not provided
Not provided
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005117 | Cardiac Complexes, Premature |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |