Trial · NCT01442038
Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI)
NCT01442038, Phase 3, Completed, Gilead Sciences; results first posted 2016-07-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI). Trials, record NCT01442038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01442038
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI)
- NCT number
- NCT01442038
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,651 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Interventions
- Ranolazine, Placebo
- First posted
- 2011-09-28
- Last updated
- 2016-07-15
- Other registries' IDs
- eudract:2011-002507-15
- Results first posted
- 2016-07-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | Baseline through end of study (average 90 weeks) | Time to event distributions were estimated by the Kaplan-Meier (KM) method. 1 month = 28 days; 1 calendar year = 365 days. |
| Secondary | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | Baseline through end of study (average 90 weeks) | Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days. |
| Secondary | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | Baseline through end of study (average 90 weeks) | Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days. |
| Secondary | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | Baseline through end of study (average 90 weeks) | Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | Baseline through end of study (average 90 weeks) | Full Analysis Set: all participants in the Safety Analysis Set (randomized and received at least one dose of study drug), except participants with no qualifying percutaneous coronary intervention (PCI; formerly known as angioplasty with stent)) | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | Baseline through end of study (average 90 weeks) | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | Baseline through end of study (average 90 weeks) | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | Baseline through end of study (average 90 weeks) | Full Analysis Set | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | Ranolazine | KM Estimate: 1 Month | 3.4 | percentage of participants | |
| Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | Placebo | KM Estimate: 1 Month | 2.3 | percentage of participants | |
| Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | Ranolazine | KM Estimate: 6 Months | 11.3 | percentage of participants | |
| Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | Placebo | KM Estimate: 6 Months | 10.0 | percentage of participants | |
| Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | Ranolazine | KM Estimate: 12 Months | 19.1 | percentage of participants | |
| Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | Placebo | KM Estimate: 12 Months | 17.3 | percentage of participants | |
| Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | Ranolazine | KM Estimate: 1 Calendar Year | 20.2 | percentage of participants | |
| Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | Placebo | KM Estimate: 1 Calendar Year | 18.9 | percentage of participants | |
| Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | Ranolazine | KM Estimate: 18 Months | 23.8 | percentage of participants | |
| Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | Placebo | KM Estimate: 18 Months | 25.3 | percentage of participants |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 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 | 1,332 | |
| Overall Study | STARTED | Placebo | 1,319 | |
| Overall Study | COMPLETED | Ranolazine | 1,029 | |
| Overall Study | COMPLETED | Placebo | 1,040 | |
| Overall Study | NOT COMPLETED | Ranolazine | 303 | |
| Overall Study | NOT COMPLETED | Placebo | 279 |
Source ClinicalTrials.gov
Adverse events876
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 | Angina pectoris | Cardiac disorders | Ranolazine | 161 | 1,322 | |
| other | Angina pectoris | Cardiac disorders | Placebo | 156 | 1,297 | |
| other | Constipation | Gastrointestinal disorders | Ranolazine | 167 | 1,322 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 71 | 1,297 | |
| other | Nausea | Gastrointestinal disorders | Ranolazine | 123 | 1,322 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 63 | 1,297 | |
| other | Chest pain | General disorders | Ranolazine | 97 | 1,322 | |
| other | Chest pain | General disorders | Placebo | 92 | 1,297 | |
| other | Fatigue | General disorders | Ranolazine | 99 | 1,322 | |
| other | Fatigue | General disorders | Placebo | 74 | 1,297 |
1 to 10 of 876Source ClinicalTrials.gov
See all 876 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranolazine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Ranolazine | 665 | 1,322 |
| Total, other adverse events | Placebo | 531 | 1,297 |
| Total, serious adverse events | Ranolazine | 516 | 1,322 |
| Total, serious adverse events | Placebo | 485 | 1,297 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ranolazine vs Placebo: serious adverse events |
Source 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/NCT01442038
GET https://conductscience.org/api/trials/v1/NCT01442038/results?page=2