Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
Conditions
Keywords
omega-3 carboxylic acid
Brief summary
The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.
Interventions
Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE)
DRUGcorn oil control
corn oil control arm
Sponsors
The Cleveland Clinic
IQVIA RDS Inc.
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Men or women, ≥18 years of age. 2. Patient must be on a stable diet and statin\* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria: 1. LDL-C \<100 mg/dL 2. TG level ≥180 and \<500 mg/dL and HDL-C \<42 mg/dL for men or HDL-C \<47 mg/dL for women 3. Patient is at high risk for a future cardiovascular event if at least one of the following criteria (3a, 3b or 3c)\* is present via patient history, physical exam, or medical records at the time of screening: 1. Any atherosclerotic CVD as defined in protocol. 2. History of diabetes mellitus (type 1 or 2) and ≥40 years of age for men and ≥50 years of age for women, plus one of the risk factors defined in protocol. 3. Male patients \>50 years of age or females \>60 years of age, with at least one of the risk factors defined in protocol. Key
Exclusion criteria
1\. Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl esters, or corn oil. 2.Use of fibrates, bile acid sequestrants, or niacin or its analogues (\>250 mg/day) within 4 weeks prior to Visit 2. 3.Statin naïve at Visit 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Composite of Major Adverse Cardiovascular Events (MACE) | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Composite of Coronary Events | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | Coronary events include: cardiac death (including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), non-fatal myocardial infarction (MI), emergent/elective coronary revascularization and hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed). |
| CV Death | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed), last date known to be alive, and date of non-cardiovascular death. |
| CV Death in the Subgroup of Participants With Established CVD at Baseline | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed), last date known to be alive, and date of non-cardiovascular death in the subgroup of participants with established CVD at baseline |
| All-cause Death | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) and last date known to be alive. |
| All-cause Death in the Subgroup of Participants With Established CVD at Baseline | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) and last date known to be alive in the subgroup of participants with established CVD at baseline |
| The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed). |
| The Composite of CV Events | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | CV events include: cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed). |
| The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | CV events include: cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed). |
| The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | Coronary events include: cardiac death (including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), non-fatal myocardial infarction (MI), emergent/elective coronary revascularization and hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) in the subgroup of participants with established CVD at baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Non-fatal Myocardial Infarction | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed). |
| Non-fatal Stroke | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed). |
| Hospitalization for Unstable Angina | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed). |
| Emergent/Elective Coronary Revascularization | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed). |
Countries
Australia, Belgium, Canada, China, Czechia, Denmark, Estonia, Hungary, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Russia, South Africa, South Korea, Taiwan, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
686 study sites in 22 countries randomized subjects. The first patient was enrolled on 30 October 2014 and randomized on 11 November 2014. The last patient was randomized on 12 July 2017.
Participants by arm
| Arm | Count |
|---|---|
| Epanova Omega-3 carboxylic acid 4 x 1 gram capsule | 6,539 |
| Placebo Corn oil 4 x 1 gram capsule | 6,539 |
| Total | 13,078 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 363 | 330 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Other reasons | 128 | 135 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Study terminated by sponsor | 5,854 | 5,901 |
| Overall Study | Withdrawal by Subject | 111 | 78 |
Baseline characteristics
| Characteristic | Placebo | Epanova | Total |
|---|---|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 8.98 | 62.5 years STANDARD_DEVIATION 8.98 | 62.5 years STANDARD_DEVIATION 8.98 |
| Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE | 112 Participants | 114 Participants | 226 Participants |
| Race/Ethnicity, Customized ASIAN | 657 Participants | 698 Participants | 1355 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 166 Participants | 180 Participants | 346 Participants |
| Race/Ethnicity, Customized MULTIPLE | 47 Participants | 33 Participants | 80 Participants |
| Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | 11 Participants | 10 Participants | 21 Participants |
| Race/Ethnicity, Customized NOT REPORTED | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized OTHER | 154 Participants | 159 Participants | 313 Participants |
| Race/Ethnicity, Customized UNKNOWN | 10 Participants | 4 Participants | 14 Participants |
| Race/Ethnicity, Customized WHITE | 5382 Participants | 5341 Participants | 10723 Participants |
| Region of Enrollment Australia | 54 Participants | 58 Participants | 112 Participants |
| Region of Enrollment Belgium | 51 Participants | 53 Participants | 104 Participants |
| Region of Enrollment Canada | 177 Participants | 187 Participants | 364 Participants |
| Region of Enrollment China | 356 Participants | 357 Participants | 713 Participants |
| Region of Enrollment Czech Republic | 108 Participants | 120 Participants | 228 Participants |
| Region of Enrollment Denmark | 73 Participants | 48 Participants | 121 Participants |
| Region of Enrollment Estonia | 53 Participants | 57 Participants | 110 Participants |
| Region of Enrollment Hungary | 562 Participants | 561 Participants | 1123 Participants |
| Region of Enrollment Italy | 34 Participants | 33 Participants | 67 Participants |
| Region of Enrollment Japan | 139 Participants | 166 Participants | 305 Participants |
| Region of Enrollment Korea, Republic Of | 65 Participants | 68 Participants | 133 Participants |
| Region of Enrollment Lithuania | 193 Participants | 170 Participants | 363 Participants |
| Region of Enrollment Mexico | 155 Participants | 152 Participants | 307 Participants |
| Region of Enrollment Netherlands | 215 Participants | 206 Participants | 421 Participants |
| Region of Enrollment New Zealand | 77 Participants | 74 Participants | 151 Participants |
| Region of Enrollment Poland | 492 Participants | 501 Participants | 993 Participants |
| Region of Enrollment Russia | 326 Participants | 307 Participants | 633 Participants |
| Region of Enrollment South Africa | 490 Participants | 471 Participants | 961 Participants |
| Region of Enrollment Taiwan, Province Of China | 31 Participants | 28 Participants | 59 Participants |
| Region of Enrollment Ukraine | 955 Participants | 1009 Participants | 1964 Participants |
| Region of Enrollment United Kingdom | 382 Participants | 377 Participants | 759 Participants |
| Region of Enrollment USA | 1551 Participants | 1536 Participants | 3087 Participants |
| Sex: Female, Male Female | 2279 Participants | 2289 Participants | 4568 Participants |
| Sex: Female, Male Male | 4260 Participants | 4250 Participants | 8510 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 373 / 6,539 | 333 / 6,539 |
| other Total, other adverse events | 1,405 / 6,532 | 826 / 6,535 |
| serious Total, serious adverse events | 2,259 / 6,532 | 2,195 / 6,535 |
Outcome results
Primary
The Composite of Major Adverse Cardiovascular Events (MACE)
MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epanova | The Composite of Major Adverse Cardiovascular Events (MACE) | 785 Number of Participants |
| Placebo | The Composite of Major Adverse Cardiovascular Events (MACE) | 795 Number of Participants |
p-value: 0.83795% CI: [0.9, 1.09]Regression, Cox
Secondary
All-cause Death
Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) and last date known to be alive.
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epanova | All-cause Death | 373 Number of Participants |
| Placebo | All-cause Death | 333 Number of Participants |
p-value: 0.11295% CI: [0.97, 1.31]Regression, Cox
Secondary
All-cause Death in the Subgroup of Participants With Established CVD at Baseline
Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) and last date known to be alive in the subgroup of participants with established CVD at baseline
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epanova | All-cause Death in the Subgroup of Participants With Established CVD at Baseline | Overall number of participants | 373 Number of Participants |
| Epanova | All-cause Death in the Subgroup of Participants With Established CVD at Baseline | Number of participants with established CVD at baselne | 234 Number of Participants |
| Placebo | All-cause Death in the Subgroup of Participants With Established CVD at Baseline | Overall number of participants | 333 Number of Participants |
| Placebo | All-cause Death in the Subgroup of Participants With Established CVD at Baseline | Number of participants with established CVD at baselne | 202 Number of Participants |
p-value: 0.09195% CI: [0.97, 1.42]Regression, Cox
Secondary
CV Death
Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed), last date known to be alive, and date of non-cardiovascular death.
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epanova | CV Death | 228 Number of Participants |
| Placebo | CV Death | 211 Number of Participants |
p-value: 0.37295% CI: [0.9, 1.31]Regression, Cox
Secondary
CV Death in the Subgroup of Participants With Established CVD at Baseline
Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed), last date known to be alive, and date of non-cardiovascular death in the subgroup of participants with established CVD at baseline
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epanova | CV Death in the Subgroup of Participants With Established CVD at Baseline | Overall number of participants | 228 Number of Participants |
| Epanova | CV Death in the Subgroup of Participants With Established CVD at Baseline | Number of participants with established CVD at baseline | 152 Number of Participants |
| Placebo | CV Death in the Subgroup of Participants With Established CVD at Baseline | Overall number of participants | 211 Number of Participants |
| Placebo | CV Death in the Subgroup of Participants With Established CVD at Baseline | Number of participants with established CVD at baseline | 138 Number of Participants |
p-value: 0.33695% CI: [0.89, 1.41]Regression, Cox
Secondary
The Composite of Coronary Events
Coronary events include: cardiac death (including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), non-fatal myocardial infarction (MI), emergent/elective coronary revascularization and hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epanova | The Composite of Coronary Events | 556 Number of Participants |
| Placebo | The Composite of Coronary Events | 616 Number of Participants |
p-value: 0.09295% CI: [0.81, 1.02]Regression, Cox
Secondary
The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline
Coronary events include: cardiac death (including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), non-fatal myocardial infarction (MI), emergent/elective coronary revascularization and hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) in the subgroup of participants with established CVD at baseline
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epanova | The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline | Overall number of participants | 556 Number of Participants |
| Epanova | The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline | Number of participants with established CVD at baseline | 417 Number of Participants |
| Placebo | The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline | Overall number of participants | 616 Number of Participants |
| Placebo | The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline | Number of participants with established CVD at baseline | 493 Number of Participants |
p-value: 0.01695% CI: [0.75, 0.97]Regression, Cox
Secondary
The Composite of CV Events
CV events include: cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epanova | The Composite of CV Events | 541 Number of Participants |
| Placebo | The Composite of CV Events | 517 Number of Participants |
p-value: 0.40295% CI: [0.93, 1.19]Regression, Cox
Secondary
The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline
CV events include: cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epanova | The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline | Overall number of participants | 541 Number of Participants |
| Epanova | The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline | Number of participants with established CVD at baseline | 383 Number of Participants |
| Placebo | The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline | Overall number of participants | 517 Number of Participants |
| Placebo | The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline | Number of participants with established CVD at baseline | 385 Number of Participants |
p-value: 0.9495% CI: [0.87, 1.16]Regression, Cox
Secondary
The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline
MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epanova | The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline | Overall number of participants | 785 Number of Participants |
| Epanova | The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline | Number of participants with established cardiovascular disease (CVD) at baseline | 569 Number of Participants |
| Placebo | The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline | Overall number of participants | 795 Number of Participants |
| Placebo | The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline | Number of participants with established cardiovascular disease (CVD) at baseline | 610 Number of Participants |
p-value: 0.26995% CI: [0.84, 1.05]Regression, Cox
Other Pre-specified
Emergent/Elective Coronary Revascularization
Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epanova | Emergent/Elective Coronary Revascularization | 414 Number of Participants |
| Placebo | Emergent/Elective Coronary Revascularization | 441 Number of Participants |
p-value: 0.40895% CI: [0.83, 1.08]Regression, Cox
Other Pre-specified
Hospitalization for Unstable Angina
Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epanova | Hospitalization for Unstable Angina | 87 Number of Participants |
| Placebo | Hospitalization for Unstable Angina | 104 Number of Participants |
p-value: 0.23395% CI: [0.63, 1.12]Regression, Cox
Other Pre-specified
Non-fatal Myocardial Infarction
Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epanova | Non-fatal Myocardial Infarction | 218 Number of Participants |
| Placebo | Non-fatal Myocardial Infarction | 226 Number of Participants |
p-value: 0.7795% CI: [0.81, 1.17]Regression, Cox
Other Pre-specified
Non-fatal Stroke
Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epanova | Non-fatal Stroke | 142 Number of Participants |
| Placebo | Non-fatal Stroke | 125 Number of Participants |
p-value: 0.27895% CI: [0.9, 1.45]Regression, Cox