Clinical trial NCT02104583: Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ventricular Arrhythmia
Keywords: VT
VF
Ventricular Tachycardia
Ventricular Fibrillation
shock
ATP
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24
timeFrame: Randomization up to 24 weeks
Secondary outcomes:
measure: Overall Occurrence (Total Number) of Appropriate ICD Interventions (ATP or Shock) Through End of Study
timeFrame: Randomization up to 22 months
measure: Change From Baseline in Premature Ventricular Complex (PVC) Count as Assessed by Continuous Electrocardiogram (cECG) Monitoring
timeFrame: Baseline to Week 12
measure: Change From Baseline in Nonsustained Ventricular Tachycardia (nsVT) Count as Assessed by Continuous cECG Monitoring
timeFrame: Baseline to Week 12
measure: Overall Occurrence (Total Number) of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) (Treated or Untreated) Through Week 24 and End of Study
timeFrame: Randomization up to Week 24; Randomization up to end of study (up to 22 months)
measure: Overall Occurrence (Total Number) of Electrical Storm Through Week 24 and End of Study
timeFrame: Randomization up to Week 24; Randomization up to end of study (up to 22 months)
measure: Overall Occurrence (Total Number) of Inappropriate ICD Interventions Through Week 24 and End of Study
timeFrame: Randomization up to Week 24; Randomization up to end of study (up to 22 months)
measure: Change in Left Ventricular Systolic and Diastolic Function as Assessed by Left Ventricular Ejection Fraction (LVEF)
timeFrame: Baseline to Week 12; Baseline to Week 24
measure: Time From First Dose of Study Drug to the First Occurrence of Appropriate ICD Interventions (ATP or Shock) or Cardiovascular (CV) Death
timeFrame: From first dose of study drug up to 22 months
measure: Time From First Dose of Study Drug to the First Occurrence of CV Hospitalization, Emergency Room (ER) Visit, or CV Death
timeFrame: From first dose of study drug up to 22 months
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Cardiovascular Associates of Mesa
state: Arizona
city: Long Beach
country: United States
facility: Long Beach Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Newport Beach
country: United States
facility: Radin Cardiovascular Medical Associates
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates, PC
state: Colorado
city: Atlantis
country: United States
facility: Atlantic Clinical Research Collaborative
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular and Interventional Consultants
state: Florida
city: Clearwater
country: United States
facility: Coastal Cardiology Consultants PA dba Heart and Vascular Institute of Florida
state: Florida
city: Largo
country: United States
facility: The Heart Institute at Largo
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Heart and Vascular Institute
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic PA
state: Florida
city: Athens
country: United States
facility: Athens Regional Specialty Services
state: Georgia
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Midland
country: United States
facility: Mid Michigan Medical Center - Midland
state: Michigan
city: Saginaw
country: United States
facility: Michigan Cardiovascular Institute
state: Michigan
city: Great Falls
country: United States
facility: Great Falls Clinic
state: Montana
city: Omaha
country: United States
facility: Methodist Physicians Clinic Heart Consultants
state: Nebraska
city: Albuquerque
country: United States
facility: New Mexico Hear Institute
state: New Mexico
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohiohealth Corporation
state: Ohio
city: Camp Hill
country: United States
facility: Capital Area Research
state: Pennsylvania
city: Wormleysburg
country: United States
facility: CardioVascular Institute
state: Pennsylvania
city: Warwick
country: United States
facility: Care New England Health Care, Kent Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Austin
country: United States
facility: Seton Heart Institute
state: Texas
city: Dallas
country: United States
facility: Cardiovascular Research Institute of Dallas
state: Texas
city: Houston
country: United States
facility: West Houston Area Clinical Trial Consultants
state: Texas
city: Burlington
country: United States
facility: The University of Vermont Medical Center
state: Vermont
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Falls Church
country: United States
facility: Virginia Heart Group Ltd
state: Virginia
city: Lynchburg
country: United States
facility: Stroobants Cardiovascular Center
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Marshfield
country: United States
facility: Marshfield Clinic Research Foundation
state: Wisconsin
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Chum Hotel Dieu
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke CHUS
state: Quebec
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Prague
country: Czechia
facility: Charles University Hospital Královské Vinohrady
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet, The Heart Center
city: Hellerup
country: Denmark
facility: Gentofte Hospitak, Deparment of Cardiology
city: Odense C
country: Denmark
facility: Odense University Hospital/Department of Cardiology
city: Berlin
country: Germany
facility: Vivantes Humboldt Klinikum
city: Goettingen
country: Germany
facility: University Medical Center Goettingen
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Munich
country: Germany
facility: Medizinische Klinik und Poliklinik I Abteilung für Kardiologie
city: Regensburg
country: Germany
facility: Klinikum der Universität Regensburg
city: Riesa
country: Germany
facility: Gemeinschaftspraxis für Innere Medizin
city: Balatonfüred
country: Hungary
facility: State Hospital for Cardiology
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Kórház
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Kórház
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Israel
country: Israel
facility: Tel Aviv University/Meir Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Breda
country: Netherlands
facility: Amphia ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Nieuwegein
country: Netherlands
facility: St.Antonius Hospital
city: Zwolle
country: Netherlands
facility: Isala
city: Katowice
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach Górnosla
city: Kraków
country: Poland
facility: Collegium Medicum Uniwersytetu Jagiellonskiego
city: Lodz
country: Poland
facility: Medical University of Lodz
city: Lódz
country: Poland
facility: Mc Tronik Specjalistyczny Gabinet Kontroli Stymulatorow Serca Dr N. Med. Michal Chudzik
city: Lódz
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Andrzej Lubinski
city: Sopot
country: Poland
facility: NZOZ Sopockie Centrum badan Kardiolog.ProCordis pawel Miekus
city: Szczecin
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Jarosław Kaźmierczak
city: Warsaw
country: Poland
facility: Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego
city: Warszawa
country: Poland
facility: Szpital Wolski im Dr Anny Gostynskiej SP ZOZ
city: Warszawa
country: Poland
facility: Warszawski Uniwersytet Medyczny
city: Wroclaw
country: Poland
facility: Medical University Wroclaw
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: