Trial Outcomes & Findings for DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation (NCT NCT02666742)

Results Overview

Transient ischemic attack(TIA) - defined as a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

246 participants

Primary outcome timeframe

First 30 days of post ablation

Results posted on

2022-08-22

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	123	123
Overall Study COMPLETED	123	123
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DOAC n=123 Participants 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.	Aspirin n=123 Participants 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 n=246 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 12.5 • n=123 Participants	58.3 years STANDARD_DEVIATION 14.7 • n=123 Participants	59.95 years STANDARD_DEVIATION 13.7438 • n=246 Participants
Sex: Female, Male Female	24 Participants n=123 Participants	19 Participants n=123 Participants	43 Participants n=246 Participants
Sex: Female, Male Male	99 Participants n=123 Participants	104 Participants n=123 Participants	203 Participants n=246 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Anti-arrhythmic drugs	100 Participants n=123 Participants	90 Participants n=123 Participants	190 Participants n=246 Participants

PRIMARY outcome

Timeframe: First 30 days of post ablation

Population: this is a population group undergoing VT or premature ventricular contraction (PVC) 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.

Outcome measures

Outcome measures
Measure	DOAC n=123 Participants DOAC is a blood thinner group	Aspirin n=123 Participants 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.
Number of Participants With Transient Ischemic Attack	6 participants	22 participants

PRIMARY outcome

Timeframe: First 30 days of post ablation

Population: This is a population group undergoing VT or PVC ablation

Stroke - incidence of ischemic stroke - defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction.

Outcome measures

Outcome measures
Measure	DOAC n=123 Participants DOAC is a blood thinner group	Aspirin n=123 Participants 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.
Number of Participants With Stroke	0 Participants	8 Participants

PRIMARY outcome

Timeframe: 24 Hours post ablation

Population: This is a population group undergoing VT or PVC ablation

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

Outcome measures

Outcome measures
Measure	DOAC n=123 Participants DOAC is a blood thinner group	Aspirin n=123 Participants 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.
Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours	15 Participants	28 Participants

PRIMARY outcome

Timeframe: 24 Hours to 30 days of post ablation

Population: This is a population group undergoing VT or PVC ablation

MRI detected asymptomatic cerebrovascular events (ACE) at 30 days follow-up.

Outcome measures

Outcome measures
Measure	DOAC n=123 Participants DOAC is a blood thinner group	Aspirin n=123 Participants 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.
Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days	8 Participants	22 Participants

SECONDARY outcome

Timeframe: Day 30

Population: patients who meet inclusion criteria

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.