Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator

NCT ID: NCT02104583

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 313 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-10-31

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).

Conditions

Ventricular Arrhythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Eleclazine 3 mg

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.

Group Type: EXPERIMENTAL

Eleclazine

Intervention Type: DRUG

Eleclazine tablets administered orally

Eleclazine 6 mg

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.

Group Type: EXPERIMENTAL

Eleclazine

Intervention Type: DRUG

Eleclazine tablets administered orally

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo to match eleclazine

Intervention Type: DRUG

Placebo to match eleclazine tablets administered orally

Interventions

Eleclazine

Eleclazine tablets administered orally

Intervention Type: DRUG

Placebo to match eleclazine

Placebo to match eleclazine tablets administered orally

Intervention Type: DRUG

Other Intervention Names

GS-6615

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Cardiovascular Associates of Mesa

Mesa, Arizona, United States

Long Beach Memorial Hospital

Long Beach, California, United States

Good Samaritan Hospital

Los Angeles, California, United States

Radin Cardiovascular Medical Associates

Newport Beach, California, United States

Regional Cardiology Associates

Sacramento, California, United States

South Denver Cardiology Associates, PC

Littleton, Colorado, United States

Atlantic Clinical Research Collaborative

Atlantis, Florida, United States

Clearwater Cardiovascular and Interventional Consultants

Clearwater, Florida, United States

Coastal Cardiology Consultants PA dba Heart and Vascular Institute of Florida

Clearwater, Florida, United States

The Heart Institute at Largo

Largo, Florida, United States

Charlotte Heart and Vascular Institute

Port Charlotte, Florida, United States

Florida Medical Clinic PA

Zephyrhills, Florida, United States

Athens Regional Specialty Services

Athens, Georgia, United States

Washington Adventist Hospital

Takoma Park, Maryland, United States

Mid Michigan Medical Center - Midland

Midland, Michigan, United States

Michigan Cardiovascular Institute

Saginaw, Michigan, United States

Great Falls Clinic

Great Falls, Montana, United States

Methodist Physicians Clinic Heart Consultants

Omaha, Nebraska, United States

New Mexico Hear Institute

Albuquerque, New Mexico, United States

New York Methodist Hospital

Brooklyn, New York, United States

Durham VA Medical Center

Durham, North Carolina, United States

Aultman Hospital

Canton, Ohio, United States

Ohiohealth Corporation

Columbus, Ohio, United States

Capital Area Research

Camp Hill, Pennsylvania, United States

CardioVascular Institute

Wormleysburg, Pennsylvania, United States

Care New England Health Care, Kent Hospital

Warwick, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Volunteer Research Group

Knoxville, Tennessee, United States

Seton Heart Institute

Austin, Texas, United States

Cardiovascular Research Institute of Dallas

Dallas, Texas, United States

West Houston Area Clinical Trial Consultants

Houston, Texas, United States

The University of Vermont Medical Center

Burlington, Vermont, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Virginia Heart Group Ltd

Falls Church, Virginia, United States

Stroobants Cardiovascular Center

Lynchburg, Virginia, United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

Marshfield Clinic Research Foundation

Marshfield, Wisconsin, United States

Kingston General Hospital

Kingston, Ontario, Canada

Chum Hotel Dieu

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke CHUS

Sherbrooke, Quebec, Canada

QEII Health Sciences Centre

Halifax, , Canada

Fakultni nemocnice Olomouc

Olomouc, , Czechia

Charles University Hospital Královské Vinohrady

Prague, , Czechia

Aalborg University Hospital

Aalborg, , Denmark

Rigshospitalet, The Heart Center

Copenhagen, , Denmark

Gentofte Hospitak, Deparment of Cardiology

Hellerup, , Denmark

Odense University Hospital/Department of Cardiology

Odense C, , Denmark

Vivantes Humboldt Klinikum

Berlin, , Germany

University Medical Center Goettingen

Göttingen, , Germany

University of Heidelberg

Heidelberg, , Germany

Medizinische Klinik und Poliklinik I Abteilung für Kardiologie

Munich, , Germany

Klinikum der Universität Regensburg

Regensburg, , Germany

Gemeinschaftspraxis für Innere Medizin

Riesa, , Germany

State Hospital for Cardiology

Balatonfüred, , Hungary

Budai Irgalmasrendi Kórház

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, , Hungary

Zala Megyei Kórház

Zalaegerszeg, , Hungary

HaEmek Medical Center

Afula, , Israel

Rambam Health Care Campus

Haifa, , Israel

Tel Aviv University/Meir Medical Center

Israel, , Israel

Shaare Zedek Medical Center

Jerusalem, , Israel

Hadassah Medical Center

Jerusalem, , Israel

Galilee Medical Center

Nahariya, , Israel

Sheba Medical Center

Ramat Gan, , Israel

Kaplan Medical Center

Rehovot, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Amphia ziekenhuis

Breda, , Netherlands

Catharina ziekenhuis

Eindhoven, , Netherlands

Maastricht University Medical Center

Maastricht, , Netherlands

St.Antonius Hospital

Nieuwegein, , Netherlands

Isala

Zwolle, , Netherlands

Samodzielny Publiczny Szpital Kliniczny nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach Górnosla

Katowice, , Poland

Collegium Medicum Uniwersytetu Jagiellonskiego

Krakow, , Poland

Medical University of Lodz

Lodz, , Poland

Mc Tronik Specjalistyczny Gabinet Kontroli Stymulatorow Serca Dr N. Med. Michal Chudzik

Lódz, , Poland

Indywidualna Specjalistyczna Praktyka Lekarska Andrzej Lubinski

Lódz, , Poland

NZOZ Sopockie Centrum badan Kardiolog.ProCordis pawel Miekus

Sopot, , Poland

Indywidualna Specjalistyczna Praktyka Lekarska Jarosław Kaźmierczak

Szczecin, , Poland

Szpital Wolski im Dr Anny Gostynskiej SP ZOZ

Warsaw, , Poland

Warszawski Uniwersytet Medyczny

Warsaw, , Poland

Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego

Warsaw, , Poland

Medical University Wroclaw

Wroclaw, , Poland

Countries

United States; Canada; Czechia; Denmark; Germany; Hungary; Israel; Netherlands; Poland

Other Identifiers

2013-004430-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-356-0101

Identifier Type: -

Identifier Source: org_study_id