Trial · NCT02104583
Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator
NCT02104583, Phase 2, Completed, Gilead Sciences; results first posted 2019-04-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator. Trials, record NCT02104583. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02104583
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator
- NCT number
- NCT02104583
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 313 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Ventricular Arrhythmia
- Interventions
- Eleclazine, Placebo to match eleclazine
- First posted
- 2014-04-04
- Last updated
- 2019-04-09
- Other registries' IDs
- eudract:2013-004430-15
- Results first posted
- 2019-04-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Overall Occurrence (Total Number) of Appropriate ICD Interventions (ATP or Shock) Through End of Study | Randomization up to 22 months | |
| Secondary | Change From Baseline in Premature Ventricular Complex (PVC) Count as Assessed by Continuous Electrocardiogram (cECG) Monitoring | Baseline to Week 12 | 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. |
| Secondary | Change From Baseline in Nonsustained Ventricular Tachycardia (nsVT) Count as Assessed by Continuous cECG Monitoring | Baseline to Week 12 | 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. |
| Secondary | 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) | |
| Secondary | 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) | An electrical storm was defined as ≥ 3 separate episodes of ventricular arrhythmia within a 24-hour period terminated by ICD. |
| Secondary | Overall Occurrence (Total Number) of Inappropriate ICD Interventions Through Week 24 and End of Study | Randomization up to Week 24; Randomization up to end of study (up to 22 months) | |
| Secondary | Change in Left Ventricular Systolic and Diastolic Function as Assessed by Left Ventricular Ejection Fraction (LVEF) | Baseline to Week 12; Baseline to Week 24 | 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. |
| Secondary | Time From First Dose of Study Drug to the First Occurrence of Appropriate ICD Interventions (ATP or Shock) or Cardiovascular (CV) Death | From first dose of study drug up to 22 months | 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. |
| Secondary | Time From First Dose of Study Drug to the First Occurrence of CV Hospitalization, Emergency Room (ER) Visit, or CV Death | From first dose of study drug up to 22 months | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Participants in the Full Analysis Set-ICD \[all participants who were randomized into the study and received at least 1 dose of study medication, restricted to participants who had at least 1 postbaseline ICD/cardiac resynchronization therapy-defibrillator (CRT-D) interrogation\] with available data were analyzed. | events | MEAN |
| SECONDARY | Overall Occurrence (Total Number) of Appropriate ICD Interventions (ATP or Shock) Through End of Study | Randomization up to 22 months | Participants in the Full Analysis Set-ICD with available data were analyzed. | events | MEAN |
| SECONDARY | Change From Baseline in Premature Ventricular Complex (PVC) Count as Assessed by Continuous Electrocardiogram (cECG) Monitoring | Baseline to Week 12 | Participants in the Full Analysis Set (all participants who were randomized into the study and received at least 1 dose of study medication) with available data were analyzed. | episodes/48 hours | MEAN |
| SECONDARY | Change From Baseline in Nonsustained Ventricular Tachycardia (nsVT) Count as Assessed by Continuous cECG Monitoring | Baseline to Week 12 | Participants in the Full Analysis Set with available data were analyzed. | episodes/48 hours | MEAN |
| SECONDARY | 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) | Participants in the Full Analysis Set-ICD with available data were analyzed. | events | MEAN |
| SECONDARY | 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) | Participants in the Full Analysis Set-ICD with available data were analyzed. | events | MEAN |
| SECONDARY | Overall Occurrence (Total Number) of Inappropriate ICD Interventions Through Week 24 and End of Study | Randomization up to Week 24; Randomization up to end of study (up to 22 months) | Participants in the Full Analysis Set-ICD with available data were analyzed. | events | MEAN |
| SECONDARY | Change in Left Ventricular Systolic and Diastolic Function as Assessed by Left Ventricular Ejection Fraction (LVEF) | Baseline to Week 12; Baseline to Week 24 | Participants in the Full Analysis Set with available data were analyzed. | percentage of blood | MEAN |
| SECONDARY | Time From First Dose of Study Drug to the First Occurrence of Appropriate ICD Interventions (ATP or Shock) or Cardiovascular (CV) Death | From first dose of study drug up to 22 months | Participants in the Full Analysis Set with available data were analyzed. | days | MEDIAN |
| SECONDARY | Time From First Dose of Study Drug to the First Occurrence of CV Hospitalization, Emergency Room (ER) Visit, or CV Death | From first dose of study drug up to 22 months | Participants in the Full Analysis Set with available data were analyzed. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group79
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24 | Cohort 1 Eleclazine 3 mg | 3.3 | Standard Deviation 6.99 | events | |
| Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24 | Cohort 1 Placebo | 1.9 | Standard Deviation 3.79 | events | |
| Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24 | Cohort 2 Eleclazine 3 mg | 2.6 | Standard Deviation 6.8 | events | |
| Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24 | Cohort 2 Eleclazine 6 mg | 1.1 | Standard Deviation 2.09 | events | |
| Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24 | Cohort 2 Placebo | 1.5 | Standard Deviation 3.92 | events | |
| Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24 | Cohorts 1 and 2, Eleclazine 3 mg | 2.8 | Standard Deviation 6.86 | events | |
| Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24 | Cohorts 1 and 2, Placebo | 1.7 | Standard Deviation 3.86 | events | |
| Overall Occurrence (Total Number) of Appropriate ICD Interventions (ATP or Shock) Through End of Study | Cohort 1 Eleclazine 3 mg | 5.0 | Standard Deviation 7.92 | events | |
| Overall Occurrence (Total Number) of Appropriate ICD Interventions (ATP or Shock) Through End of Study | Cohort 1 Placebo | 7.2 | Standard Deviation 20.89 | events | |
| Overall Occurrence (Total Number) of Appropriate ICD Interventions (ATP or Shock) Through End of Study | Cohort 2 Eleclazine 3 mg | 3.8 | Standard Deviation 8.82 | events |
1 to 10 of 79Source ClinicalTrials.gov
See all 79 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 Eleclazine 3 mg | 48 | |
| Overall Study | STARTED | Cohort 1 Placebo | 46 | |
| Overall Study | STARTED | Cohort 2 Eleclazine 3 mg | 70 | |
| Overall Study | STARTED | Cohort 2 Eleclazine 6 mg | 74 | |
| Overall Study | STARTED | Cohort 2 Placebo | 75 | |
| Overall Study | COMPLETED | Cohort 1 Eleclazine 3 mg | 30 | |
| Overall Study | COMPLETED | Cohort 1 Placebo | 35 | |
| Overall Study | COMPLETED | Cohort 2 Eleclazine 3 mg | 54 | |
| Overall Study | COMPLETED | Cohort 2 Eleclazine 6 mg | 57 | |
| Overall Study | COMPLETED | Cohort 2 Placebo | 63 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events645
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial fibrillation | Cardiac disorders | Cohort 1 Eleclazine 3 mg | 4 | 48 | |
| other | Atrial fibrillation | Cardiac disorders | Cohort 1 Placebo | 2 | 46 | |
| other | Atrial fibrillation | Cardiac disorders | Cohort 2 Eleclazine 3 mg | 4 | 70 | |
| other | Atrial fibrillation | Cardiac disorders | Cohort 2 Eleclazine 6 mg | 2 | 73 | |
| other | Atrial fibrillation | Cardiac disorders | Cohort 2 Placebo | 3 | 75 | |
| other | Ventricular tachycardia | Cardiac disorders | Cohort 1 Eleclazine 3 mg | 8 | 48 | |
| other | Ventricular tachycardia | Cardiac disorders | Cohort 1 Placebo | 2 | 46 | |
| other | Ventricular tachycardia | Cardiac disorders | Cohort 2 Eleclazine 3 mg | 8 | 70 | |
| other | Ventricular tachycardia | Cardiac disorders | Cohort 2 Eleclazine 6 mg | 7 | 73 | |
| other | Ventricular tachycardia | Cardiac disorders | Cohort 2 Placebo | 9 | 75 |
1 to 10 of 645Source ClinicalTrials.gov
See all 645 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 Eleclazine 3 mg | ||
| Total, all-cause mortality | Cohort 1 Placebo | ||
| Total, all-cause mortality | Cohort 2 Eleclazine 3 mg | ||
| Total, all-cause mortality | Cohort 2 Eleclazine 6 mg | ||
| Total, all-cause mortality | Cohort 2 Placebo | ||
| Total, other adverse events | Cohort 1 Eleclazine 3 mg | 32 | 48 |
| Total, other adverse events | Cohort 1 Placebo | 26 | 46 |
| Total, other adverse events | Cohort 2 Eleclazine 3 mg | 42 | 70 |
| Total, other adverse events | Cohort 2 Eleclazine 6 mg | 34 | 73 |
| Total, other adverse events | Cohort 2 Placebo | 33 | 75 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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