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Ventricular ArrhythmiaPhase 2TEMPONCT02104583

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

A Phase 2 study testing Eleclazine in people with Ventricular Arrhythmia, run by Gilead Sciences at 84 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ventricular Arrhythmia
What is being tested?
Eleclazine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
313 participants
Where
84 sitesin 9 countries
Study dates
Sep 2014to Oct 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

84 sites in 9 countries.

84 sites in 9 countries

United States37 sites

  • New Mexico Hear Institute

    Albuquerque, New Mexico, 87102

  • Athens Regional Specialty Services

    Athens, Georgia, 30606

  • Atlantic Clinical Research Collaborative

    Atlantis, Florida, 33462

  • Seton Heart Institute

    Austin, Texas, 78705

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Capital Area Research

    Camp Hill, Pennsylvania, 17011

  • Aultman Hospital

    Canton, Ohio, 44708

  • Medical University of South Carolina

    Charleston, South Carolina, 29403

  • Clearwater Cardiovascular and Interventional Consultants

    Clearwater, Florida, 33756

  • Coastal Cardiology Consultants PA dba Heart and Vascular Institute of Florida

    Clearwater, Florida, 33756

  • Ohiohealth Corporation

    Columbus, Ohio, 43214

  • Cardiovascular Research Institute of Dallas

    Dallas, Texas, 75231

  • Durham VA Medical Center

    Durham, North Carolina, 27705

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Virginia Heart Group Ltd

    Falls Church, Virginia, 22042

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • West Houston Area Clinical Trial Consultants

    Houston, Texas, 77094

  • Volunteer Research Group

    Knoxville, Tennessee, 37920

  • The Heart Institute at Largo

    Largo, Florida, 33770

  • South Denver Cardiology Associates, PC

    Littleton, Colorado, 80120

  • Long Beach Memorial Hospital

    Long Beach, California, 90806

  • Good Samaritan Hospital

    Los Angeles, California, 90017

  • Stroobants Cardiovascular Center

    Lynchburg, Virginia, 24501

  • Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • Cardiovascular Associates of Mesa

    Mesa, Arizona, 85206

  • Mid Michigan Medical Center - Midland

    Midland, Michigan, 48670

  • Radin Cardiovascular Medical Associates

    Newport Beach, California, 92663

  • Methodist Physicians Clinic Heart Consultants

    Omaha, Nebraska, 68114

  • Charlotte Heart and Vascular Institute

    Port Charlotte, Florida, 33952

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014

  • Regional Cardiology Associates

    Sacramento, California, 95819

  • Michigan Cardiovascular Institute

    Saginaw, Michigan, 48601

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • Care New England Health Care, Kent Hospital

    Warwick, Rhode Island, 02886

  • CardioVascular Institute

    Wormleysburg, Pennsylvania, 17043

  • Florida Medical Clinic PA

    Zephyrhills, Florida, 33542

Other trials in United States

Poland11 sites

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

    Katowice, 40-635

  • Collegium Medicum Uniwersytetu Jagiellonskiego

    Krakow, 31-501

  • Medical University of Lodz

    Lodz, 91-347

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

    Lódz, 90-553

  • Indywidualna Specjalistyczna Praktyka Lekarska Andrzej Lubinski

    Lódz, 91-078

  • NZOZ Sopockie Centrum badan Kardiolog.ProCordis pawel Miekus

    Sopot, 81-717

  • Indywidualna Specjalistyczna Praktyka Lekarska Jarosław Kaźmierczak

    Szczecin, 70-203

  • Szpital Wolski im Dr Anny Gostynskiej SP ZOZ

    Warsaw, 01-211

  • Warszawski Uniwersytet Medyczny

    Warsaw, 02-097

  • Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego

    Warsaw, 04-628

  • Medical University Wroclaw

    Wroclaw

Other trials in Poland

Israel9 sites

  • HaEmek Medical Center

    Afula, 18101

  • Rambam Health Care Campus

    Haifa, 31096

  • Tel Aviv University/Meir Medical Center

    Israel, 44299

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Medical Center

    Jerusalem, 91120

  • Galilee Medical Center

    Nahariya, 22100

  • Sheba Medical Center

    Ramat Gan, 52621

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Germany6 sites

  • Vivantes Humboldt Klinikum

    Berlin, 13585

  • University Medical Center Goettingen

    Göttingen

  • University of Heidelberg

    Heidelberg, '69120

  • Medizinische Klinik und Poliklinik I Abteilung für Kardiologie

    Munich, 81377

  • Klinikum der Universität Regensburg

    Regensburg, 93053

  • Gemeinschaftspraxis für Innere Medizin

    Riesa, 1587

Other trials in Germany

Netherlands6 sites

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam

  • Amphia ziekenhuis

    Breda

  • Catharina ziekenhuis

    Eindhoven

  • Maastricht University Medical Center

    Maastricht

  • St.Antonius Hospital

    Nieuwegein, 3430EM

  • Isala

    Zwolle

Other trials in Netherlands

Hungary5 sites

  • State Hospital for Cardiology

    Balatonfüred, 8231

  • Budai Irgalmasrendi Kórház

    Budapest, 1027

  • Semmelweis Egyetem

    Budapest, 1122

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1134

  • Zala Megyei Kórház

    Zalaegerszeg, 8900

Other trials in Hungary

Canada4 sites

  • QEII Health Sciences Centre

    Halifax, B3H 3A7

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • Chum Hotel Dieu

    Montreal, Quebec, H2W 1T8

  • Centre Hospitalier Universitaire de Sherbrooke CHUS

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

Denmark4 sites

  • Aalborg University Hospital

    Aalborg, 9000

  • Rigshospitalet, The Heart Center

    Copenhagen

  • Gentofte Hospitak, Deparment of Cardiology

    Hellerup, 2900

  • Odense University Hospital/Department of Cardiology

    Odense C, 5000

Other trials in Denmark

Czechia2 sites

  • Fakultni nemocnice Olomouc

    Olomouc

  • Charles University Hospital Královské Vinohrady

    Prague

Other trials in Czechia

About this study

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)

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).

Being tested
Eleclazine, Placebo to match eleclazine
Keywords
VT, VF, Ventricular Tachycardia, Ventricular Fibrillation, shock, ATP
Medical subject headings
Tachycardia, Ventricular, Ventricular Fibrillation, Shock

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EleclazineDrug

    Also called GS-6615

    Eleclazine tablets administered orally

  • Placebo to match eleclazineDrug

    Placebo to match eleclazine tablets administered orally

Study groups in NCT02104583
Study groupRoleWhat they receive
Eleclazine 3 mgExperimentalParticipants 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.
Receives: Drug: Eleclazine
Eleclazine 6 mgExperimentalParticipants 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.
Receives: Drug: Eleclazine
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo to match eleclazine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Randomization up to 24 weeks

Secondary outcomes (9)

  1. Overall Occurrence (Total Number) of Appropriate ICD Interventions (ATP or Shock) Through End of Study

    Measured: Randomization up to 22 months

  2. Change From Baseline in Premature Ventricular Complex (PVC) Count as Assessed by Continuous Electrocardiogram (cECG) Monitoring

    PVC count per 48 hours was obtained from cECG readings at Baseline and Week 12. Change in PVC from baseline was measured in units of number of episodes/48 hours. Change from baseline was calculated as the value at Week 12 minus the value at Baseline.

    Measured: Baseline to Week 12

  3. Change From Baseline in Nonsustained Ventricular Tachycardia (nsVT) Count as Assessed by Continuous cECG Monitoring

    The count of nsVTs per 48 hours was obtained from cECG readings at Baseline and Week 12. Change in nsVT from baseline was measured in units of number of episodes/48 hours. Change from baseline was calculated as the value at Week 12 minus the value at Baseline.

    Measured: Baseline to Week 12

  4. Overall Occurrence (Total Number) of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) (Treated or Untreated) Through Week 24 and End of Study

    Measured: Randomization up to Week 24; Randomization up to end of study (up to 22 months)

  5. Overall Occurrence (Total Number) of Electrical Storm Through Week 24 and End of Study

    An electrical storm was defined as ≥ 3 separate episodes of ventricular arrhythmia within a 24-hour period terminated by ICD.

    Measured: Randomization up to Week 24; Randomization up to end of study (up to 22 months)

  6. Overall Occurrence (Total Number) of Inappropriate ICD Interventions Through Week 24 and End of Study

    Measured: Randomization up to Week 24; Randomization up to end of study (up to 22 months)

  7. Change in Left Ventricular Systolic and Diastolic Function as Assessed by Left Ventricular Ejection Fraction (LVEF)

    LVEF is a measure of how much blood is pumped out of the left ventricle of the heart. Change from baseline was calculated as the value at Week 12 or 24 minus the value at Baseline.

    Measured: Baseline to Week 12; Baseline to Week 24

  8. Time From First Dose of Study Drug to the First Occurrence of Appropriate ICD Interventions (ATP or Shock) or Cardiovascular (CV) Death

    CV deaths were determined through the adjudication by an external independent clinical event committee (CEC). The deaths that were adjudicated as undetermined were considered cardiovascular related. For each participant, the time from the first dose of study drug to the beginning of the earliest appropriate ICD intervention through the last day on study or, in absence of appropriate ICD interventions, to a CV death was derived as (first event date - first dose date + 1). The participants without appropriate ICD interventions or CV death were censored at the last day on study. As planned, data was reported only for Cohort 2 and combined Cohorts 1 and 2. Time to first occurrence of an appropriate ICD interventions or CV death was analyzed using Kaplan-Meier (KM) estimates.

    Measured: From first dose of study drug up to 22 months

  9. Time From First Dose of Study Drug to the First Occurrence of CV Hospitalization, Emergency Room (ER) Visit, or CV Death

    CV hospitalizations, CV ER visits, and CV deaths were determined through the adjudication by the CEC. The events that were adjudicated as undetermined were considered cardiovascular related. For each participant, the time from the first dose of study drug to the first CV hospitalization or CV ER visit through the last day on study or, in absence of CV hospitalizations or CV ER visits, to a CV death were derived as (first event date - first dose date + 1). The participants without CV hospitalizations, CV ER visits, or CV death were censored at the last day on study. As planned, data was reported only for Cohort 2 and combined Cohorts 1 and 2. Time to first occurrence of CV hospitalization, ER visit, or CV death was analyzed using KM estimates.

    Measured: From first dose of study drug up to 22 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionSep 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
313 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02104583
Sponsor's protocol ID
GS-US-356-0101
Other IDs
2013-004430-15
Acronym
TEMPO
Status last verified
Mar 2019
First submitted
2 Apr 2014
Last updated
9 Apr 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eleclazine in people with Ventricular Arrhythmia, run by Gilead Sciences at 84 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Poland, Israel, Germany, Netherlands and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24 (time frame: Randomization up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02104583.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.

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