Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD) Clinical Trial
— STRENGTHOfficial title:
A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH)
| Verified date | August 2021 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 13078 |
| Est. completion date | May 27, 2020 |
| Est. primary completion date | May 27, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | 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. |
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| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Huntsville | Alabama |
| United States | Research Site | Hyannis | Massachusetts |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | Irving | Texas |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Johnson City | Tennessee |
| United States | Research Site | Johnstown | Pennsylvania |
| United States | Research Site | Kalamazoo | Michigan |
| United States | Research Site | Kingsport | Tennessee |
| United States | Research Site | Knoxville | Tennessee |
| United States | Research Site | Knoxville | Tennessee |
| United States | Research Site | La Crosse | Wisconsin |
| United States | Research Site | Lake Worth | Florida |
| United States | Research Site | Lakeland | Florida |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Laurelton | New York |
| United States | Research Site | Lawrence | New York |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Lynchburg | Virginia |
| United States | Research Site | Madison | Wisconsin |
| United States | Research Site | Manassas | Virginia |
| United States | Research Site | Manassas | Virginia |
| United States | Research Site | Marietta | Georgia |
| United States | Research Site | Marion | Ohio |
| United States | Research Site | Maumee | Ohio |
| United States | Research Site | Mesa | Arizona |
| United States | Research Site | Mesa | Arizona |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Middleburg Hts | Ohio |
| United States | Research Site | Midwest City | Oklahoma |
| United States | Research Site | Milpitas | California |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Mission | Texas |
| United States | Research Site | Monroe | Louisiana |
| United States | Research Site | Mooresville | North Carolina |
| United States | Research Site | Morganton | North Carolina |
| United States | Research Site | Mount Pleasant | South Carolina |
| United States | Research Site | Muncie | Indiana |
| United States | Research Site | Muscle Shoals | Alabama |
| United States | Research Site | Naperville | Illinois |
| United States | Research Site | Natrona Heights | Pennsylvania |
| United States | Research Site | New Port Richey | Florida |
| United States | Research Site | New York | New York |
| United States | Research Site | Newport | Pennsylvania |
| United States | Research Site | Newport Beach | California |
| United States | Research Site | Norman | Oklahoma |
| United States | Research Site | Northridge | California |
| United States | Research Site | Oakbrook Terrace | Illinois |
| United States | Research Site | Odessa | Texas |
| United States | Research Site | Ogden | Utah |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Orem | Utah |
| United States | Research Site | Overland Park | Kansas |
| United States | Research Site | Palm Springs | California |
| United States | Research Site | Pembroke Pines | Florida |
| United States | Research Site | Pembroke Pines | Florida |
| United States | Research Site | Pensacola | Florida |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Pinellas Park | Florida |
| United States | Research Site | Plano | Texas |
| United States | Research Site | Port Charlotte | Florida |
| United States | Research Site | Port Gibson | Mississippi |
| United States | Research Site | Port Matilda | Pennsylvania |
| United States | Research Site | Port Orchard | Washington |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Quincy | Massachusetts |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Rapid City | South Dakota |
| United States | Research Site | Rock Hill | South Carolina |
| United States | Research Site | Rocky Mount | North Carolina |
| United States | Research Site | Saginaw | Michigan |
| United States | Research Site | Saginaw | Michigan |
| United States | Research Site | Salisbury | North Carolina |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | Sandy Springs | Georgia |
| United States | Research Site | Santa Ana | California |
| United States | Research Site | Santa Rosa | California |
| United States | Research Site | Saratoga Springs | New York |
| United States | Research Site | Savannah | Georgia |
| United States | Research Site | Sewell | New Jersey |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | Sicklerville | New Jersey |
| United States | Research Site | Simpsonville | South Carolina |
| United States | Research Site | Slidell | Louisiana |
| United States | Research Site | Southampton | New York |
| United States | Research Site | Spartanburg | South Carolina |
| United States | Research Site | Spring Hill | Florida |
| United States | Research Site | Sterling | Illinois |
| United States | Research Site | Tamarac | Florida |
| United States | Research Site | Tarzana | California |
| United States | Research Site | Tempe | Arizona |
| United States | Research Site | Tipton | Pennsylvania |
| United States | Research Site | Traverse City | Michigan |
| United States | Research Site | Troy | New York |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Tupelo | Mississippi |
| United States | Research Site | Valparaiso | Indiana |
| United States | Research Site | Victoria | Texas |
| United States | Research Site | Waterbury | Connecticut |
| United States | Research Site | Wausau | Wisconsin |
| United States | Research Site | Wilkes-Barre | Pennsylvania |
| United States | Research Site | Wilmington | North Carolina |
| United States | Research Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | IQVIA RDS Inc., The Cleveland Clinic |
United States, Australia, Belgium, Canada, China, Czechia, Denmark, Estonia, Hungary, Italy, Japan, Korea, Republic of, Lithuania, Mexico, Netherlands, New Zealand, Poland, Russian Federation, South Africa, Taiwan, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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). | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | |
| Other | 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). | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | |
| Other | 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). | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | |
| Other | 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). | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | |
| 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). | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | |
| 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). | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | |
| 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). | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | |
| 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). | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | |
| 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). | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | |
| 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 | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | |
| 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. | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | |
| 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 | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | |
| 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. | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | |
| 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 | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure |