NCT02104583已完成2 期
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging, Parallel Group Study to Evaluate the Effect of GS-6615 on Ventricular Arrhythmia in Subjects With Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 84
- 主要终点
- Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Eleclazine 3 mg
Experimental
Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 20 months.
干预措施: Eleclazine (Drug)
Eleclazine 6 mg
Experimental
Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 6 mg daily as maintenance for up to approximately 20 months.
干预措施: Eleclazine (Drug)
Placebo
Placebo Comparator
Participants will receive a single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.
干预措施: Placebo to match eleclazine (Drug)
结局指标
主要结局
Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24
时间窗: Randomization up to 24 weeks
次要结局
- Overall Occurrence (Total Number) of Appropriate ICD Interventions (ATP or Shock) Through End of Study(Randomization up to 22 months)
- Change From Baseline in Premature Ventricular Complex (PVC) Count as Assessed by Continuous Electrocardiogram (cECG) Monitoring(Baseline to Week 12)
- Time From First Dose of Study Drug to the First Occurrence of CV Hospitalization, Emergency Room (ER) Visit, or CV Death(From first dose of study drug up to 22 months)
- Change From Baseline in Nonsustained Ventricular Tachycardia (nsVT) Count as Assessed by Continuous cECG Monitoring(Baseline to Week 12)
- Overall Occurrence (Total Number) of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) (Treated or Untreated) Through Week 24 and End of Study(Randomization up to Week 24; Randomization up to end of study (up to 22 months))
- Overall Occurrence (Total Number) of Electrical Storm Through Week 24 and End of Study(Randomization up to Week 24; Randomization up to end of study (up to 22 months))
- Overall Occurrence (Total Number) of Inappropriate ICD Interventions Through Week 24 and End of Study(Randomization up to Week 24; Randomization up to end of study (up to 22 months))
- Change in Left Ventricular Systolic and Diastolic Function as Assessed by Left Ventricular Ejection Fraction (LVEF)(Baseline to Week 12; Baseline to Week 24)
- Time From First Dose of Study Drug to the First Occurrence of Appropriate ICD Interventions (ATP or Shock) or Cardiovascular (CV) Death(From first dose of study drug up to 22 months)
研究者
研究点 (84)
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