Phase 2
N=313
Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator
Ventricular Arrhythmia
Bottom Line
View on ClinicalTrials.gov: NCT02104583 ↗Enrolled (actual)
313
Serious AEs
42.3%
Results posted
Apr 2019
Primary outcome: Primary: Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24 — 3.3; 1.9; 2.6; 1.1 events — p=0.152
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Eleclazine (Drug); Placebo to match eleclazine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24 |
3.3; 1.9; 2.6; 1.1; 1.5; 2.8 | 0.152 |
| SECONDARY Overall Occurrence (Total Number) of Appropriate ICD Interventions (ATP or Shock) Through End of Study |
5.0; 7.2; 3.8; 1.2; 2.0; 4.3 | — |
| SECONDARY Change From Baseline in Premature Ventricular Complex (PVC) Count as Assessed by Continuous Electrocardiogram (cECG) Monitoring |
4282; -2347; -594; -39; 1541 | — |
| SECONDARY Change From Baseline in Nonsustained Ventricular Tachycardia (nsVT) Count as Assessed by Continuous cECG Monitoring |
44; -14; -67; 46; 2 | — |
| SECONDARY Overall Occurrence (Total Number) of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) (Treated or Untreated) Through Week 24 and End of Study |
3.56; 2.07; 2.74; 1.44; 1.61; 5.98 | — |
| SECONDARY Overall Occurrence (Total Number) of Electrical Storm Through Week 24 and End of Study |
0.15; 0.15; 0.23; 0.03; 0.09; 0.21 | — |
| SECONDARY Overall Occurrence (Total Number) of Inappropriate ICD Interventions Through Week 24 and End of Study |
0.17; 0.15; 0.14; 0.12; 0.39; 0.31 | — |
| SECONDARY Change in Left Ventricular Systolic and Diastolic Function as Assessed by Left Ventricular Ejection Fraction (LVEF) |
35; 38; 38; 38; 40; 3 | — |
| SECONDARY Time From First Dose of Study Drug to the First Occurrence of Appropriate ICD Interventions (ATP or Shock) or Cardiovascular (CV) Death |
252.0; NA; NA; 243.0; 265.0 | — |
| SECONDARY Time From First Dose of Study Drug to the First Occurrence of CV Hospitalization, Emergency Room (ER) Visit, or CV Death |
NA; NA; NA; NA; NA | — |
Summary
The primary objective of this study is to evaluate the effect of eleclazine (GS-6615) compared to placebo on the overall occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions (antitachycardia pacing [ATP] or shock) in adults with ICD or cardiac resynchronization therapy-defibrillator (CRT-D).
Eligibility Criteria
Key Inclusion Criteria
- Have an ICD or CRT-D implanted for primary or secondary prevention and at least one ICD intervention for ventricular tachycardia/ventricular fibrillation (VT/VF) [shock or ATP] within 60 days prior to screening or a documented VT/VF episode (prior to implantation) within 60 days prior to screening
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
- Must be hemodynamically stable
Key Exclusion Criteria
- New York Heart Association (NYHA) Class IV heart failure
- Myocardial infarction, unstable angina, coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) within 4 weeks prior to screening or during the screening period before randomization
- Hemodynamically significant primary obstructive valvular disease
- History of congenital heart disease
- Inherited arrhythmia such as Brugada syndrome. Individuals with long QT syndrome Type 3 (LQT-3) or hypertrophic cardiomyopathy (HCM) may be considered.
- Individuals who are being considered for cardiac transplantation and are on a cardiac transplant list
- History of seizures or epilepsy
- Cardiac ablation within 3 months prior to screening or planned cardiac ablation during the study
- Severe renal impairment
- Abnormal liver function tests
- Currently taking Class I and Class III antiarrhythmic drugs; such medications should be discontinued 5 half-lives (or 28 days for chronic use of amiodarone) prior to randomization
- Currently taking drugs or products that are strong inhibitors or inducers of CYP3A; such medications should be discontinued 5 half-lives prior to randomization
- Currently taking ranolazine; ranolazine should be discontinued at least 7 days prior to randomization
- Females who are pregnant or are breastfeeding
- Individuals with a subcutaneous ICD
- Body mass index (BMI) ≥ 36 kg/m^2
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02104583). 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.