Angina Pectoris, Coronary Artery Disease
Conditions
Brief summary
This study will evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization post-percutaneous coronary intervention (PCI; formerly known as angioplasty with stent) on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.
Interventions
DRUGRanolazine
Subjects will receive ranolazine 500 milligrams (mg) twice daily for 7 days, followed by 1000 mg administered orally twice daily for the duration of the study. Subjects receiving a moderate CYP3A4 inhibitor will receive ranolazine 500 mg or placebo administered orally twice a day for the duration of the concomitant therapy.
DRUGPlacebo
Subjects will receive one tablet of matching placebo twice daily for 7 days, followed by two tablets of matching placebo twice daily for the duration of the study. Subjects receiving a moderate CYP3A4 inhibitor will receive ranolazine 500 mg or placebo administered orally twice a day for the duration of the concomitant therapy.
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent 2. Males and females aged 18 years and older 3. History of chronic angina defined as at least 2 episodes of anginal pain or discomfort in the chest, jaw, shoulder, back, neck, or arm that is precipitated by exertion or emotional stress, and relieved by rest or sublingual nitroglycerin, which occurred on at least 2 separate days and at least 14 days prior to PCI (in the case of staged PCI procedures, at least 14 days prior to the first PCI in the series). Participants may or may not have additional angina episodes within the 14 days prior to their first PCI in the series, as well as any time prior to Randomization. 4. PCI for any indication (ACS or non-ACS). For the purposes of stratification at randomization, ACS will be defined as hospitalization for anginal pain or discomfort within the previous 24 hours to their hospitalization with any one (or more) of the following criteria: i. Elevated troponin or creatinine kinase-MB (CK-MB) consistent with myocardial infarction (MI), as reported by local laboratory and measured prior to index PCI ii. Electrocardiographic changes (including transient changes) comprising new or presumably new ST segment depression ≥ 0.1 mV (≥ 1 mm), or ST segment elevation ≥ 0.1 mV (≥ 1 mm) in at least 2 contiguous leads, or new or presumably new Left Bundle Branch Block 5. Randomization within 14 days post-PCI. In the case of staged PCI procedures, randomization has to occur within 14 days of the last PCI in the series. Participants may be randomized starting on the day of PCI and anytime during the following 14 days. PCI is defined as an attempt to cross the lesion with a wire with the intention of performing revascularization. 6. Post-PCI (post the last PCI for staged procedures) evidence of incomplete revascularization defined as the presence of one or more visually estimated ≥ 50% stenoses in one or more coronary arteries with reference vessel diameter of at least 2.0 mm, whether in the target vessel or in a non-target vessel regardless of the presence or absence of coronary collaterals. In the case of a participant post-coronary artery bypass grafting (CABG), incomplete revascularization is defined as the presence of one or more visually estimated ≥ 50% stenoses in an unbypassed epicardial vessel with a reference diameter of ≥ 2.0 mm, or one or more visually estimated ≥ 50% stenoses in a bypass graft supplying an otherwise unrevascularized myocardial territory. 7. Clinically stable post-PCI. Participants randomized in-hospital on day of planned discharge or in clinic are considered stable. Participants randomized in-hospital prior to day of planned discharge must meet all of the following criteria: i. CK-MB \< 3 times the upper limit of normal (ULN) at least 3 hours post-PCI, or if ≥ 3 times the ULN with evidence of decreasing CK-MB (decreased by at least 20% from the prior measurement) as reported by local laboratory. If CK-MB is not available, a participant must have evidence of normal or decreasing troponin levels (by at least 20% from the prior measurement) at least 3 hours post-PCI, as reported by local laboratory. ii. Systolic blood pressure ≥ 90 mm Hg and not receiving pressors or inotropes iii. No current requirement for an intra-aortic balloon pump (IABP) or any left ventricular assist device iv. No current requirement for intravenous (IV) nitroglycerin 8. Ability and willingness to comply with all study procedures during the course of the study 9. Females of childbearing potential must have a negative pregnancy test at Screening (unless surgically sterile or post-menopausal) and must agree to use highly effective contraception methods from Screening throughout the duration of study treatment and for 14 days following the last dose of study drug.
Exclusion criteria
1. Any future planned revascularization (including staged procedures) or possible planned revascularization (ie, planned stress test to assess the imminent need for additional revascularization). Future planned stress tests for purposes of monitoring are permitted but strongly discouraged. Participants may be enrolled after the last PCI in the staged series or once a decision is made not to perform a follow up PCI, as long as Randomization occurs within 14 days from the last PCI. If a participant has had a stress test post-PCI and prior to Randomization and no further intervention is planned, the participant may be enrolled within 14 days from the last PCI. 2. Unrevascularized left main coronary artery stenosis ≥ 50%. Participants with a history of CABG to the left coronary system will be considered to have a revascularized left main if at least one graft is patent. 3. Major complication during or after the index PCI (in the case of staged PCI, the last in the series) including: i. Major bleeding (TIMI Bleeding classification or any bleeding requiring blood transfusion of ≥ 2 units of red blood cells) ii. Coronary perforation requiring treatment iii. Procedural complication requiring surgery (including CABG or peripheral vascular surgery) 4. Stroke within 90 days prior to Randomization, or any history of stroke with permanent major neurologic disability (eg, aphasia or significant motor dysfunction) 5. Cardiogenic shock within 90 days prior to Randomization (transient decreases in blood pressure without clinical sequelae are not considered to be cardiogenic shock) 6. New York Heart Association (NYHA) Class III or IV heart failure 7. Severe renal insufficiency as assessed by an estimated glomerular filtration rate \< 30 mL/min/1.73m2 using the 4 variable modification of diet in renal disease (MDRD) equation per local laboratory (based on the last available measurement prior to Randomization, collected within 1 month prior to the index PCI \[in the case of staged PCI, the last in the series\]) 8. Liver cirrhosis 9. Use of Class Ia, Ic, or Class III antiarrhythmics, except for amiodarone 10. Current treatment with strong inhibitors of CYP3A 11. Current treatment with CYP3A4 inducers or P-gp inducers 12. Participants taking \> 20 mg simvastatin daily or \> 40 mg lovastatin daily who cannot reduce the dose to 20 mg once daily for simvastatin or 40 mg once daily for lovastatin, or who cannot switch to another statin 13. Participants taking greater than a total of 1000 mg daily of metformin who cannot reduce the dose to a maximum total of 1000 mg daily (additional anti-diabetic medications may be added as clinically indicated to allow participants to decrease their metformin dose and maintain glycemic control) 14. Previous treatment with ranolazine for \> 7 consecutive days within 30 days prior to Randomization, or known hypersensitivity or intolerance to ranolazine or to any of the excipients 15. Participation in another investigational drug or investigational device study within 30 days prior to Randomization (participation in registries is allowed) 16. Women who are pregnant or breast feeding 17. Non-coronary artery disease comorbid conditions (eg, advanced malignancy, severe aortic stenosis) which are likely to result in death within 2 years of Randomization 18. Any condition that in the opinion of the investigator would preclude compliance with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Austria, Belgium, Canada, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Russia, Spain, Sweden, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States, Canada, Europe, Russia, and Israel. The first participant was screened on 03 November 2011. The last study visit occurred on 09 February 2015.
Pre-assignment details
2734 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Ranolazine Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study) | 1,322 |
| Placebo Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study) | 1,297 |
| Total | 2,619 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 26 | 15 |
| Overall Study | Death | 35 | 29 |
| Overall Study | Investigator-Initiated Early Closure | 44 | 43 |
| Overall Study | Investigator's Discretion | 13 | 16 |
| Overall Study | Lost to Follow-up | 37 | 51 |
| Overall Study | Participant Withdrew Consent | 137 | 102 |
| Overall Study | Protocol Deviation | 9 | 20 |
| Overall Study | Study Terminated By Sponsor | 2 | 3 |
Baseline characteristics
| Characteristic | Ranolazine | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 10.51 | 63.4 years STANDARD_DEVIATION 10.06 | 63.4 years STANDARD_DEVIATION 10.29 |
| Age, Customized 65-74 Years | 402 participants | 383 participants | 785 participants |
| Age, Customized < 65 Years | 714 participants | 719 participants | 1433 participants |
| Age, Customized ≥ 75 Years | 206 participants | 195 participants | 401 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 3 participants | 3 participants |
| Race/Ethnicity, Customized Asian | 16 participants | 10 participants | 26 participants |
| Race/Ethnicity, Customized Black or African American | 49 participants | 43 participants | 92 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 72 participants | 64 participants | 136 participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 1219 participants | 1208 participants | 2427 participants |
| Race/Ethnicity, Customized Not Permitted | 23 participants | 16 participants | 39 participants |
| Race/Ethnicity, Customized Not Reported | 28 participants | 24 participants | 52 participants |
| Race/Ethnicity, Customized Other | 29 participants | 28 participants | 57 participants |
| Race/Ethnicity, Customized Unknown | 3 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized White | 1203 participants | 1196 participants | 2399 participants |
| Region of Enrollment Austria | 12 participants | 15 participants | 27 participants |
| Region of Enrollment Belgium | 20 participants | 21 participants | 41 participants |
| Region of Enrollment Canada | 80 participants | 85 participants | 165 participants |
| Region of Enrollment Czech Republic | 31 participants | 44 participants | 75 participants |
| Region of Enrollment France | 22 participants | 15 participants | 37 participants |
| Region of Enrollment Germany | 34 participants | 27 participants | 61 participants |
| Region of Enrollment Israel | 111 participants | 109 participants | 220 participants |
| Region of Enrollment Italy | 28 participants | 33 participants | 61 participants |
| Region of Enrollment Netherlands | 13 participants | 13 participants | 26 participants |
| Region of Enrollment Poland | 203 participants | 172 participants | 375 participants |
| Region of Enrollment Russian Federation | 154 participants | 168 participants | 322 participants |
| Region of Enrollment Spain | 80 participants | 87 participants | 167 participants |
| Region of Enrollment Sweden | 19 participants | 25 participants | 44 participants |
| Region of Enrollment United Kingdom | 16 participants | 17 participants | 33 participants |
| Region of Enrollment United States | 499 participants | 466 participants | 965 participants |
| Sex: Female, Male Female | 276 Participants | 260 Participants | 536 Participants |
| Sex: Female, Male Male | 1046 Participants | 1037 Participants | 2083 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 665 / 1,322 | 531 / 1,297 |
| serious Total, serious adverse events | 516 / 1,322 | 485 / 1,297 |
Outcome results
Primary
Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization
Time to event distributions were estimated by the Kaplan-Meier (KM) method. 1 month = 28 days; 1 calendar year = 365 days.
Time frame: Baseline through end of study (average 90 weeks)
Population: 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))
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 1 Month | 3.4 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 6 Months | 11.3 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 12 Months | 19.1 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 1 Calendar Year | 20.2 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 18 Months | 23.8 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 24 Months | 27.6 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 2 Calendar Years | 30.7 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 30 months | 31.1 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 36 Months | 32.2 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 3 Calendar Years | NA percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 30 months | 33.8 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 1 Month | 2.3 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 24 Months | 29.4 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 6 Months | 10.0 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 3 Calendar Years | 37.8 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 12 Months | 17.3 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 2 Calendar Years | 31.0 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 1 Calendar Year | 18.9 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 36 Months | 37.8 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization | KM Estimate: 18 Months | 25.3 percentage of participants |
p-value: 0.4895% CI: [0.818, 1.099]Cox Proportional Hazards Model
Secondary
Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death
Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.
Time frame: Baseline through end of study (average 90 weeks)
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 24 Months | 1.7 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 12 Months | 1.0 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 2 Calendar Years | 1.9 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 6 Months | 0.6 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 30 months | 1.9 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 1 Calendar Year | 1.1 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 36 Months | 1.9 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 18 Months | 1.5 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 3 Calendar Years | 1.9 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 1 Month | 0.2 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 3 Calendar Years | 1.7 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 1 Month | 0.1 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 6 Months | 0.4 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 12 Months | 0.9 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 18 Months | 1.4 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 24 Months | 1.7 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 2 Calendar Years | 1.7 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 30 months | 1.7 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 36 Months | 1.7 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death | KM Estimate: 1 Calendar Year | 1.0 percentage of participants |
p-value: 0.8295% CI: [0.579, 1.994]Cox Proportional Hazards Model
Secondary
Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction
Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.
Time frame: Baseline through end of study (average 90 weeks)
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 1 Month | 1.2 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 6 Months | 3.8 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 12 Months | 5.8 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 1 Calendar Year | 6.2 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 18 Months | 7.3 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 24 Months | 8.7 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 2 Calendar Years | 10.0 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 30 months | 10.9 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 36 Months | 10.9 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 3 Calendar Years | 10.9 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 30 months | 10.1 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 1 Month | 0.6 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 24 Months | 9.4 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 6 Months | 3.3 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 3 Calendar Years | 13.4 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 12 Months | 5.7 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 2 Calendar Years | 9.4 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 1 Calendar Year | 6.2 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 36 Months | 13.4 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction | KM Estimate: 18 Months | 8.5 percentage of participants |
p-value: 0.8195% CI: [0.745, 1.256]Cox Proportional Hazards Model
Secondary
Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death
Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.
Time frame: Baseline through end of study (average 90 weeks)
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 1 Month | 0.2 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 6 Months | 0.5 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 12 Months | 0.5 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 1 Calendar Year | 0.5 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 18 Months | 0.5 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 24 Months | 0.5 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 2 Calendar Years | 0.7 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 30 months | 0.7 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 36 Months | 0.7 percentage of participants |
| Ranolazine | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 3 Calendar Years | 0.7 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 30 months | 0.9 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 1 Month | 0.1 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 24 Months | 0.9 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 6 Months | 0.2 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 3 Calendar Years | 0.9 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 12 Months | 0.5 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 2 Calendar Years | 0.9 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 1 Calendar Year | 0.5 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 36 Months | 0.9 percentage of participants |
| Placebo | Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death | KM Estimate: 18 Months | 0.8 percentage of participants |
p-value: 0.495% CI: [0.244, 1.691]Cox Proportional Hazards Model