Trial · NCT01215253
Ranolazine Implantable Cardioverter-Defibrillator Trial
NCT01215253, Phase 3, Completed, University of Rochester; results first posted 2018-06-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ranolazine Implantable Cardioverter-Defibrillator Trial. Trials, record NCT01215253. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01215253
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ranolazine Implantable Cardioverter-Defibrillator Trial
- NCT number
- NCT01215253
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,012 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Ischemic Cardiomyopathy, Nonischemic Cardiomyopathy, Heart Failure
- Interventions
- Ranolazine
- First posted
- 2010-10-06
- Last updated
- 2018-08-27
- Results first posted
- 2018-06-15
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF) or Death | 2 years of follow-up on average | Primary endpoint of the study will be defined as a composite endpoint consisting of Ventricular Tachycardia or Ventricular Fibrillation requiring antitachycardia pacing (ATP) therapy, implantable cardioverter-defibrillator (ICD) shock, or death, whichever occurs first. |
| Secondary | Number of Patients With VT or VF Requiring ICD Shock or Death | 2 years of follow-up on average | Implantable cardioverter-defibrillator (ICD) shock for VT or VF or death, whichever occurs first. |
| Secondary | Number of Recurrent Episodes of VT or VF Requiring Antitachycardia Pacing (ATP) or ICD Shock Therapies | 2 years of follow-up on average | Total number of recurrent ICD therapies requiring antitachycardia pacing (ATP) or shock will be analyzed, not just first event |
| Secondary | Number of Patients With First Inappropriate ICD Shock | 2 years of follow-up on average | Number of patients with first inappropriate ICD shock for other reasons than VT or VF |
| Secondary | Number of Patients With Hospitalization for Cardiac Causes or Death, Whichever Occurred First. | 2 years of follow-up on average | Number of patients with a composite endpoint of cardiovascular hospitalization or death, whichever occurred first. |
| Secondary | Number of Patients With Heart Failure Hospitalization or Death, Whichever Occurred First | 2 years of follow-up on average | Number of patients with a composite endpoint of heart failure hospitalization or death, whichever occurred first. |
| Secondary | Death | 2 years of follow-up on average | Death as a safety endpoint of the trial |
| Secondary | Mean Meters Walked in 6 Minutes | 1 year of follow-up | Exercise capacity measured by the 6-minute walk test |
| Secondary | Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 1 year follow-up | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a new, self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. The scale ranges from 0-100 with lower scores indicating worse outcomes. |
| Secondary | Number of Recurrent Inappropriate ICD Shocks | 2 years of follow-up on average | Number of recurrent inappropriate ICD shocks in all patients combined. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF) or Death | 2 years of follow-up on average | This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With VT or VF Requiring ICD Shock or Death | 2 years of follow-up on average | This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Recurrent Episodes of VT or VF Requiring Antitachycardia Pacing (ATP) or ICD Shock Therapies | 2 years of follow-up on average | This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included. | VT/VF events | COUNT_OF_UNITS |
| SECONDARY | Number of Patients With First Inappropriate ICD Shock | 2 years of follow-up on average | This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Hospitalization for Cardiac Causes or Death, Whichever Occurred First. | 2 years of follow-up on average | This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Heart Failure Hospitalization or Death, Whichever Occurred First | 2 years of follow-up on average | This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Death | 2 years of follow-up on average | This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Meters Walked in 6 Minutes | 1 year of follow-up | Data was not collected on 86 patients in the placebo arm and 99 patients in the Ranolazine arm. | meters | MEAN |
| SECONDARY | Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 1 year follow-up | Data was not collected in 42 patients in the placebo arm and 61 patients in the Ranolazine arm. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Number of Patients Whose First VT/VF Required Antitachycardia Pacing (ATP) | 2 years of follow-up on average | This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF) or Death | Ranolazine | 174 | Participants | ||
| Number of Patients With Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF) or Death | Placebo | 198 | Participants | ||
| Number of Patients With VT or VF Requiring ICD Shock or Death | Ranolazine | 131 | Participants | ||
| Number of Patients With VT or VF Requiring ICD Shock or Death | Placebo | 145 | Participants | ||
| Number of Recurrent Episodes of VT or VF Requiring Antitachycardia Pacing (ATP) or ICD Shock Therapies | Ranolazine | 433 | VT/VF events | ||
| Number of Recurrent Episodes of VT or VF Requiring Antitachycardia Pacing (ATP) or ICD Shock Therapies | Placebo | 650 | VT/VF events | ||
| Number of Patients With First Inappropriate ICD Shock | Ranolazine | 16 | Participants | ||
| Number of Patients With First Inappropriate ICD Shock | Placebo | 20 | Participants | ||
| Number of Patients With Hospitalization for Cardiac Causes or Death, Whichever Occurred First. | Ranolazine | 237 | Participants | ||
| Number of Patients With Hospitalization for Cardiac Causes or Death, Whichever Occurred First. | Placebo | 222 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ranolazine | 510 | |
| Overall Study | STARTED | Placebo | 502 | |
| Overall Study | COMPLETED | Ranolazine | 424 | |
| Overall Study | COMPLETED | Placebo | 439 | |
| Overall Study | NOT COMPLETED | Ranolazine | 86 | |
| Overall Study | NOT COMPLETED | Placebo | 63 |
Source ClinicalTrials.gov
Adverse events4
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 | dizziness | General disorders | Ranolazine | 39 | 510 | |
| other | dizziness | General disorders | Placebo | 11 | 502 | |
| other | nausea | Gastrointestinal disorders | Ranolazine | 30 | 510 | |
| other | nausea | Gastrointestinal disorders | Placebo | 6 | 502 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranolazine | 70 | 510 |
| Total, all-cause mortality | Placebo | 78 | 502 |
| Total, other adverse events | Ranolazine | 69 | 510 |
| Total, other adverse events | Placebo | 17 | 502 |
| Total, serious adverse events | Ranolazine | 0 | 510 |
| Total, serious adverse events | Placebo | 0 | 502 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HL096607 | Late Sodium Current Blockade in High-Risk ICD Patients - CCC - Lead Application | ZAREBA, WOJCIECH | UNIVERSITY OF ROCHESTER | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2010 to 2015 |
Source NIH RePORTER
Trial comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ranolazine vs Placebo: Number of Patients With Heart Failure Hospitalization or Death, Whichever Occurred First | Trial comparisons |
| Ranolazine vs Placebo: Number of Patients Whose First VT/VF Required Antitachycardia Pacing (ATP) | Trial comparisons |
| Ranolazine vs Placebo: Number of Patients With Hospitalization for Cardiac Causes or Death, Whichever Occurred First. | Trial comparisons |
| Ranolazine vs Placebo: Number of Patients With VT or VF Requiring ICD Shock or Death | Trial comparisons |
| Ranolazine vs Placebo: Death | Trial comparisons |
| Ranolazine vs Placebo: Number of Patients Whose First VT/VF Required ICD Shock | Trial comparisons |
| Ranolazine vs Placebo: Number of Patients With Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF) or Death | Trial comparisons |
| Ranolazine vs Placebo: deaths from any cause | Trial comparisons |
| Ranolazine vs Placebo: Number of Patients With First Inappropriate ICD Shock | Trial comparisons |
| Ranolazine vs Placebo: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01215253
GET https://conductscience.org/api/trials/v1/NCT01215253/results?page=2