STROKE-VT: DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation

• Sponsor: Kansas City Heart Rhythm Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02666742
• Collaborator: Kansas City Heart Rhythm Research Foundation (Other)
• Enrollment: 246
• Locations: 5
• Arms: 2
• Actual Duration (Months): 50.4
• Patients Per Site: 49.2
• Patients Per Site Per Month: 1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia; Premature Ventricular Contraction; Stroke	Drug: DOAC; Drug: Aspirin	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 246 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: SafeTy and Efficacy of Direct Oral Anticoagulant Versus Aspirin for Reduction Of RisK of CErebrovascular Events in Patients Undergoing Ventricular Tachycardia Ablation (STROKE-VT)
• Actual Study Start Date: Feb 16, 2017
• Actual Primary Completion Date: May 1, 2020
• Actual Study Completion Date: Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DOAC (Direct Oral Anticoagulant) Participants will be asked to take standard dose approved for stroke prophylaxis	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.; Other Names: Direct Oral Anti Coagulants Rivaroxaban Apixiban Dabigatran Edoxaban
Active Comparator: Aspirin Participants will be asked to take 81 milligrams by mouth once per day.	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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours [24 Hours post ablation]

   MRI detected asymptomatic cerebrovascular events (ACE) at 24 hours.

4. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. Number of Participants With Groin Hematoma [Day 30]

   A hematoma is a collection of blood outside of a blood vessel.

6. 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.

7. 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.

8. Number of Participants With In-hospital Mortality [Day 30]

   Death occurring during the hospital stay.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
2	KCHRF	Overland Park	Kansas	United States	66221
3	Montefiore Medical Center	Bronx	New York	United States	10467
4	TCAI	Austin	Texas	United States	78701
5	Jayadeva Institute of Medical Sciences	Bengaluru	Karnataka	India

Sponsors and Collaborators

• Kansas City Heart Rhythm Institute
• Kansas City Heart Rhythm Research Foundation

Investigators

• Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Research Foundation

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 1, 2018

More Information

Publications

• 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. Review.
• Ghanbari H, Başer K, Jongnarangsin K, Chugh A, Nallamothu BK, Gillespie BW, Başer 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. Erratum in: Heart Rhythm. 2015 Jan;12(1):253. Swangasool, Arisara [corrected to Suwanagool, Arisara].

• Responsible Party: Kansas City Heart Rhythm Institute
• ClinicalTrials.gov Identifier: NCT02666742
• Other Study ID Numbers: STUDY00003241; CV185-415
• First Posted: Jan 28, 2016
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Kansas City Heart Rhythm Institute: Radiofrequency ablation; anticoagulation; Direct oral anticoagulants; Aspirin; Ventricular arrhythmia
• Additional relevant MeSH terms: Stroke; Tachycardia; Tachycardia, Ventricular; Ventricular Premature Complexes; Aspirin; Rivaroxaban; Edoxaban; Dabigatran; Anticoagulants; Coagulants

Study Results

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.

Arm/Group Title	Direct Oral Anticoagulant (DOAC)	Aspirin
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	123	123
COMPLETED	123	123
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	DOAC	Aspirin	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	123	123	246
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.6 (12.5)	58.3 (14.7)	59.95 (13.7438)
Sex: Female, Male (Count of Participants)
Female	24 19.5%	19 15.4%	43 17.5%
Male	99 80.5%	104 84.6%	203 82.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Anti-arrhythmic drugs (Count of Participants)
Count of Participants [Participants]	100 81.3%	90 73.2%	190 77.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Transient Ischemic Attack
Description	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

Outcome Measure Data

Analysis Population Description

this is a population group undergoing VT or premature ventricular contraction (PVC) ablation

Arm/Group Title	DOAC	Aspirin
Arm/Group Description	DOAC is a blood thinner group	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.
Measure Participants	123	123
Number [participants]	6 4.9%	22 17.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DOAC, Aspirin
	Comments	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.
	Type of Statistical Test	Superiority
	Comments	Continuous variables were compared by two-sample t-tests and categorical variables by chi-square test. All tests were two-tailed, and a P value less than 0.05 was considered to indicate statistical significance. Bonferroni correction was not performed due to prespecified outcomes in the trial. Analyses were performed using GraphPad 6
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Chi-squared
	Comments

2. Primary Outcome

Title	Number of Participants With Stroke
Description	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

Outcome Measure Data

Analysis Population Description

This is a population group undergoing VT or PVC ablation

Arm/Group Title	DOAC	Aspirin
Arm/Group Description	DOAC is a blood thinner group	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.
Measure Participants	123	123
Count of Participants [Participants]	0 0%	8 6.5%

3. Primary Outcome

Title	Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours
Description	MRI detected asymptomatic cerebrovascular events (ACE) at 24 hours.
Time Frame	24 Hours post ablation

Outcome Measure Data

Analysis Population Description

This is a population group undergoing VT or PVC ablation

Arm/Group Title	DOAC	Aspirin
Arm/Group Description	Participants will be asked to take standard dose approved for stroke prophylaxis 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.	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.
Measure Participants	123	123
Count of Participants [Participants]	15 12.2%	28 22.8%

4. Primary Outcome

Title	Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days
Description	MRI detected asymptomatic cerebrovascular events (ACE) at 30 days follow-up.
Time Frame	24 Hours to 30 days of post ablation

Outcome Measure Data

Analysis Population Description

This is a population group undergoing VT or PVC ablation

Arm/Group Title	DOAC	Aspirin
Arm/Group Description	Participants will be asked to take standard dose approved for stroke prophylaxis 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.	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.
Measure Participants	123	123
Count of Participants [Participants]	8 6.5%	22 17.9%

5. Secondary Outcome

Title	Number of Participants With Acute Procedure Related Complications
Description	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

Outcome Measure Data

Analysis Population Description

patients who meet inclusion criteria

Arm/Group Title	DOAC	Aspirin
Arm/Group Description	Participants will be asked to take DOAC as prescribed DOAC is a blood thinning drug, also called an anticoagulant. DOACs are 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.	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.
Measure Participants	123	123
Count of Participants [Participants]	15 12.2%	17 13.8%

6. Secondary Outcome

Title	Number of Participants With Cardiac Tamponade
Description	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

Outcome Measure Data

Analysis Population Description

Patients who meet inclusion criteria.

Arm/Group Title	DOAC	Aspirin
Arm/Group Description	Participants will be asked to take DOAC as prescribed DOAC is a blood thinning drug, also called an anticoagulant. DOACs are 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.	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.
Measure Participants	123	123
Count of Participants [Participants]	4 3.3%	3 2.4%

7. Secondary Outcome

Title	Number of Participants With Fatal Pulmonary Embolism
Description	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

Outcome Measure Data

Analysis Population Description

Patients who meet inclusion criteria.

Arm/Group Title	DOAC	Aspirin
Arm/Group Description	Participants will be asked to take DOAC as prescribed DOAC is a blood thinning drug, also called an anticoagulant. DOACs are 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.	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.
Measure Participants	123	123
Count of Participants [Participants]	0 0%	1 0.8%

8. Secondary Outcome

Title	Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD)
Description	Heart failure means that the heart isn't pumping as well as it should be.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

Patients who meet inclusion criteria.

Arm/Group Title	DOAC	Aspirin
Arm/Group Description	Participants will be asked to take DOAC as prescribed DOAC is a blood thinning drug, also called an anticoagulant. DOACs are 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.	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.
Measure Participants	123	123
Count of Participants [Participants]	4 3.3%	4 3.3%

9. Secondary Outcome

Title	Number of Participants With Groin Hematoma
Description	A hematoma is a collection of blood outside of a blood vessel.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

Patients who meet inclusion criteria.

Arm/Group Title	DOAC	Aspirin
Arm/Group Description	Participants will be asked to take DOAC as prescribed DOAC is a blood thinning drug, also called an anticoagulant. DOACs are 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.	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.
Measure Participants	123	123
Count of Participants [Participants]	3 2.4%	4 3.3%

10. Secondary Outcome

Title	Number of Participants With Retroperitoneal Bleed
Description	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

Outcome Measure Data

Analysis Population Description

Patients who meet inclusion criteria.

Arm/Group Title	DOAC	Aspirin
Arm/Group Description	Participants will be asked to take DOAC as prescribed DOAC is a blood thinning drug, also called an anticoagulant. DOACs are 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.	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.
Measure Participants	123	123
Count of Participants [Participants]	2 1.6%	2 1.6%

11. Secondary Outcome

Title	Number of Participants With Heart Block
Description	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

Outcome Measure Data

Analysis Population Description

Patients who meet inclusion criteria.

Arm/Group Title	DOAC	Aspirin
Arm/Group Description	Participants will be asked to take DOAC as prescribed DOAC is a blood thinning drug, also called an anticoagulant. DOACs are 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.	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.
Measure Participants	123	123
Count of Participants [Participants]	2 1.6%	3 2.4%

12. Secondary Outcome

Title	Number of Participants With In-hospital Mortality
Description	Death occurring during the hospital stay.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DOAC	Aspirin
Arm/Group Description	Participants will be asked to take DOAC as prescribed DOAC is a blood thinning drug, also called an anticoagulant. DOACs are 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.	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.
Measure Participants	123	123
Count of Participants [Participants]	5 4.1%	3 2.4%

Adverse Events

Time Frame	First 30 days of post ablation
Arm/Group Title	Apixaban		Aspirin
Arm/Group Description	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.		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.
All Cause Mortality
	Apixaban		Aspirin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/123 (4.1%)		3/123 (2.4%)
Serious Adverse Events
	Apixaban		Aspirin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/123 (0%)		0/123 (0%)
Other (Not Including Serious) Adverse Events
	Apixaban		Aspirin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/123 (0%)		0/123 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.