Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia (STRENGTH)
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|ClinicalTrials.gov Identifier: NCT02104817|
Recruitment Status : Active, not recruiting
First Posted : April 4, 2014
Last Update Posted : May 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)||Drug: Epanova® (omega-3 carboxylic acids) Drug: corn oil control||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13086 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH)|
|Actual Study Start Date :||October 30, 2014|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Epanova + statin, once daily
Drug: Epanova® (omega-3 carboxylic acids)
Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE)
Other Name: omega-3 carboxylic acids
Active Comparator: Corn oil
Corn oil + Statin
Drug: corn oil control
corn oil control arm
- The primary outcome measure is the time to the first occurrence of any component of the composite of MACE. [ Time Frame: Patients will remain in the study until the required number of MACE has occurred. We anticipate that patients will be in the study for up to 5 years. ]MACE components include: cardiovascular death, nonfatal MI, nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina.
- The composite measure of CV events that include the first occurrence of cardiovascular death, non-fatal MI and non-fatal stroke. [ Time Frame: We anticipate that patients will be in the study for up to 5 years. Same for all outcome measures. ]The secondary outcome measures will be analyzed the same as outlined above for the primary outcome measures.
- The composite measure of coronary events that include the first occurrence of cardiac death. [ Time Frame: Up to 5 years ]The composite measure of coronary events that include the first occurrence of cardiac death ( including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), nonfatal MI, emergent/elective coronary revascularization, or hospitalization for unstable angina.
- The first occurrence of individual components of MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. [ Time Frame: Up to 5 years ]
- Time to CV death [ Time Frame: Up to 5 years ]Cardiovascular death includes death resulting from: an acute MI, sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104817
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|Principal Investigator:||Steven Nissen, MD||The Cleveland Clinic|
|Principal Investigator:||Michael Lincoff, MD||The Cleveland Clinic|
|Principal Investigator:||Stephen Nicholls, MD||Adelaide Clinical Research|