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

NCT02104583 | Completed Phase 2 Results DMC

• 2 other identifiers: GS-US-356-01012013-004430-15
• Study Type: interventional
• Target: 313
• Locations: 9 countries
• Sites: 84

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

Keywords

VT; VF; Ventricular Tachycardia; Ventricular Fibrillation; shock; ATP

Outcome Measures

Primary Outcomes (1)

• Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24

  Randomization up to 24 weeks

Secondary Outcomes (9)

• 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

• 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)

Study Arms (3)

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.

Drug: Eleclazine

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.

Drug: Eleclazine

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.

Drug: Placebo to match eleclazine

Interventions

Eleclazine DRUG

Eleclazine tablets administered orally

Also known as: GS-6615

Eleclazine 3 mg; Eleclazine 6 mg

Placebo to match eleclazine DRUG

Placebo to match eleclazine tablets administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (84)

Cardiovascular Associates of Mesa

Mesa, Arizona, 85206, United States

Location

Long Beach Memorial Hospital

Long Beach, California, 90806, United States

Location

Good Samaritan Hospital

Los Angeles, California, 90017, United States

Location

Radin Cardiovascular Medical Associates

Newport Beach, California, 92663, United States

Location

Regional Cardiology Associates

Sacramento, California, 95819, United States

Location

South Denver Cardiology Associates, PC

Littleton, Colorado, 80120, United States

Location

Atlantic Clinical Research Collaborative

Atlantis, Florida, 33462, United States

Location

Clearwater Cardiovascular and Interventional Consultants

Clearwater, Florida, 33756, United States

Location

Coastal Cardiology Consultants PA dba Heart and Vascular Institute of Florida

Clearwater, Florida, 33756, United States

Location

The Heart Institute at Largo

Largo, Florida, 33770, United States

Location

Charlotte Heart and Vascular Institute

Port Charlotte, Florida, 33952, United States

Location

Florida Medical Clinic PA

Zephyrhills, Florida, 33542, United States

Location

Athens Regional Specialty Services

Athens, Georgia, 30606, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Mid Michigan Medical Center - Midland

Midland, Michigan, 48670, United States

Location

Michigan Cardiovascular Institute

Saginaw, Michigan, 48601, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Methodist Physicians Clinic Heart Consultants

Omaha, Nebraska, 68114, United States

Location

New Mexico Hear Institute

Albuquerque, New Mexico, 87102, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

Aultman Hospital

Canton, Ohio, 44708, United States

Location

Ohiohealth Corporation

Columbus, Ohio, 43214, United States

Location

Capital Area Research

Camp Hill, Pennsylvania, 17011, United States

Location

CardioVascular Institute

Wormleysburg, Pennsylvania, 17043, United States

Location

Care New England Health Care, Kent Hospital

Warwick, Rhode Island, 02886, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Volunteer Research Group

Knoxville, Tennessee, 37920, United States

Location

Seton Heart Institute

Austin, Texas, 78705, United States

Location

Cardiovascular Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

West Houston Area Clinical Trial Consultants

Houston, Texas, 77094, United States

Location

The University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Virginia Heart Group Ltd

Falls Church, Virginia, 22042, United States

Location

Stroobants Cardiovascular Center

Lynchburg, Virginia, 24501, United States

Location

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

Location

Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Chum Hotel Dieu

Montreal, Quebec, H2W 1T8, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

QEII Health Sciences Centre

Halifax, B3H 3A7, Canada

Location

Fakultni nemocnice Olomouc

Olomouc, Czechia

Location

Charles University Hospital Královské Vinohrady

Prague, Czechia

Location

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Rigshospitalet, The Heart Center

Copenhagen, Denmark

Location

Gentofte Hospitak, Deparment of Cardiology

Hellerup, 2900, Denmark

Location

Odense University Hospital/Department of Cardiology

Odense C, 5000, Denmark

Location

Vivantes Humboldt Klinikum

Berlin, 13585, Germany

Location

University Medical Center Goettingen

Göttingen, Germany

Location

University of Heidelberg

Heidelberg, '69120, Germany

Location

Medizinische Klinik und Poliklinik I Abteilung für Kardiologie

Munich, 81377, Germany

Location

Klinikum der Universität Regensburg

Regensburg, 93053, Germany

Location

Gemeinschaftspraxis für Innere Medizin

Riesa, 1587, Germany

Location

State Hospital for Cardiology

Balatonfüred, 8231, Hungary

Location

Budai Irgalmasrendi Kórház

Budapest, 1027, Hungary

Location

Semmelweis Egyetem

Budapest, 1122, Hungary

Location

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, 1134, Hungary

Location

Zala Megyei Kórház

Zalaegerszeg, 8900, Hungary

Location

HaEmek Medical Center

Afula, 18101, Israel

Location

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Tel Aviv University/Meir Medical Center

Israel, 44299, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Galilee Medical Center

Nahariya, 22100, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

Amphia ziekenhuis

Breda, Netherlands

Location

Catharina ziekenhuis

Eindhoven, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

St.Antonius Hospital

Nieuwegein, 3430EM, Netherlands

Location

Isala

Zwolle, Netherlands

Location

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

Katowice, 40-635, Poland

Location

Collegium Medicum Uniwersytetu Jagiellonskiego

Krakow, 31-501, Poland

Location

Medical University of Lodz

Lodz, 91-347, Poland

Location

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

Lódz, 90-553, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Andrzej Lubinski

Lódz, 91-078, Poland

Location

NZOZ Sopockie Centrum badan Kardiolog.ProCordis pawel Miekus

Sopot, 81-717, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Jarosław Kaźmierczak

Szczecin, 70-203, Poland

Location

Szpital Wolski im Dr Anny Gostynskiej SP ZOZ

Warsaw, 01-211, Poland

Location

Warszawski Uniwersytet Medyczny

Warsaw, 02-097, Poland

Location

Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego

Warsaw, 04-628, Poland

Location

Medical University Wroclaw

Wroclaw, Poland

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation; Shock

Interventions

eleclazine

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 4, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 9, 2019
• Results First Posted: April 9, 2019

Record last verified: 2019-03

Locations

DK (4); CZ (2); HU (5); NL (6); US (37); IL (9); DE (6); CA (4); PL (11)