Phase 4
N=246
DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation
Ventricular Tachycardia · Premature Ventricular Contraction · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02666742 ↗Enrolled (actual)
246
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Number of Participants With Transient Ischemic Attack — 6; 22 participants — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- DOAC (Drug); Aspirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kansas City Heart Rhythm Institute
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Transient Ischemic Attack |
6; 22 | 0.001 sig |
| PRIMARY Number of Participants With Stroke |
0; 8 | — |
| PRIMARY Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours |
15; 28 | — |
| PRIMARY Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days |
8; 22 | — |
| SECONDARY Number of Participants With Acute Procedure Related Complications |
15; 17 | — |
| SECONDARY Number of Participants With Cardiac Tamponade |
4; 3 | — |
| SECONDARY Number of Participants With Fatal Pulmonary Embolism |
0; 1 | — |
| SECONDARY Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD) |
4; 4 | — |
| SECONDARY Number of Participants With Groin Hematoma |
3; 4 | — |
| SECONDARY Number of Participants With Retroperitoneal Bleed |
2; 2 | — |
| SECONDARY Number of Participants With Heart Block |
2; 3 | — |
| SECONDARY Number of Participants With In-hospital Mortality |
5; 3 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02666742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.