Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia (STRENGTH)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by AstraZeneca
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02104817
First received: April 2, 2014
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

The study is a randomized, double-blind, well-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia 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.


Condition Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    MACE components include: (cardiovascular death, nonfatal MI, nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina)


Secondary Outcome Measures:
  • The first occurrence of any component of cardiovascular death, nonfatal MI, or nonfatal stroke [ Time Frame: We anticipate that patients will be in the study for up to 5 years. Same for all outcome measures. ] [ Designated as safety issue: No ]
    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 cardiovascular death, nonfatal MI, emergent/elective coronary revascularization, or hospitalization for unstable angina. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • The first occurrence of individual components of MACE: emergent/elective coronary revascularization, hospitalization for unstable angina, fatal or nonfatal MI, fatal or nonfatal stroke, cardiovascular death. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]
    "All cause mortality" is defined in the protocol as "death from any cause".


Estimated Enrollment: 38576
Study Start Date: September 2014
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EPANOVA
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ≥200 and <500 mg/dL and HDL-C <40 mg/dL for men or HDL-C <45 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02104817

Contacts
Contact: ClinicalTrialTransparency@astrazeneca.com ClinicalTrialTransparency@astrazeneca.com

  Show 365 Study Locations
Sponsors and Collaborators
AstraZeneca
The Cleveland Clinic
Investigators
Principal Investigator: Steven Nissen, MD The Cleveland Clinic
Principal Investigator: Michael Lincoff, MD The Cleveland Clinic
Principal Investigator: Stephen Nicholls, MD Adelaide Clinical Research
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02104817     History of Changes
Other Study ID Numbers: D5881C00004, 2014-001069-28
Study First Received: April 2, 2014
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Hypertriglyceridemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014