Overview

This trial has been completed.

Condition ventricular arrhythmia
Treatments eleclazine, placebo to match eleclazine
Phase phase 2
Sponsor Gilead Sciences
Start date September 2014
End date September 2016
Trial size 313 participants
Trial identifier NCT02104583, 2013-004430-15, GS-US-356-0101

Summary

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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking participant, care provider, investigator, outcomes assessor
Arm
(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.
eleclazine GS-6615
Eleclazine tablets administered orally
(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.
eleclazine GS-6615
Eleclazine tablets administered orally
(Placebo Comparator)
Participants will receive a single loading dose of placebo to match eleclazine followed by placebo to match eleclazine once daily for up to approximately 20 months.
placebo to match eleclazine
Placebo to match eleclazine tablets administered orally

Primary Outcomes

Measure
Overall occurrence (total number) of appropriate ICD interventions (ATP or shock) through Week 24
time frame: Up to 24 weeks

Secondary Outcomes

Measure
Overall occurrence (total number) of appropriate ICD interventions (ATP or shock) through end of study
time frame: Up to 20 months
Change in PVC
time frame: Baseline; Week 12
Change in nsVT
time frame: Baseline; Week 12
Overall occurrence (total number) of ventricular tachycardia/ventricular fibrillation (treated or untreated) through Week 24
time frame: Up to 24 weeks
Overall occurrence (total number) of ventricular tachycardia/ventricular fibrillation (treated or untreated) through the end of the study
time frame: Up to 20 months
Time from randomization to the first occurrence of appropriate ICD interventions (ATP or shock) or cardiovascular (CV) death
time frame: Up to 20 months
Overall occurrence (total number) of electrical storm through Week 24
time frame: Up to 24 weeks
Overall occurrence (total number) of electrical storm through the end of study
time frame: Up to 20 months
Overall occurrence (total number) of inappropriate ICD interventions through Week 24
time frame: Up to 24 weeks
Overall occurrence (total number) of inappropriate ICD interventions through the end of the study
time frame: Up to 20 months
Time from randomization to the first occurrence of CV hospitalization, emergency room (ER) visit, or CV death
time frame: Up to 20 months
Change in left ventricular systolic and diastolic function as assessed by echocardiography
time frame: Weeks 12 and 24

Eligibility Criteria

All participants from 18 years up to 80 years old.

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

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Gilead Sciences.