A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction with EpaNova in HiGh Cardiovascular Risk PatienTs with Hypertriglyceridemia (STRENGTH)
- Conditions
- heart and vascular disease10013317increased glyceride (type of fat) levels1001928010047066
- Registration Number
- NL-OMON47312
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 533
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, where the qualifying lipid parameters should be obtained from the same visit:
a. LDL-C <100 mg/dL (<2.59 mmol/L). Patient will also qualify if LDL-C *100 mg/dL
(*2.59 mmol/L) and if on a high-intensity or maximally tolerated moderate- or lowintensity
statin dose, with or without ezetimibe therapy, for at least 4 weeks (see
Appendix D). The maximum tolerated dosage of a statin is defined as the approved dose
per local label that the patient can tolerate without unacceptable adverse effects such as
muscle aches/pain/weakness or elevations in liver enzymes or creatine kinase (CK) that
are determined by the investigator to be clinically relevant and due to statin therapy.
b. TG *180 and < 500 mg/dL (*2.03 and < 5.65 mmol/L) and HDL-C
<42 mg/dL (1.09 mmol/L) for men or HDL-C <47 mg/dL (1.22 mmol/L)
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:
a. Any atherosclerotic CVD as defined by one or more of the following:
* previous clinical myocardial infarction (MI) *30 days prior to randomization
* percutaneous coronary intervention (PCI) including balloon angioplasty and
coronary stenting * 6 months prior to randomization
* coronary artery bypass grafting (CABG) *30 days prior to randomization
* coronary angiogram including computed tomography angiogram (CTA)
showing<=> 50% stenosis in at least one native or graft
vessel
* anginal symptoms with a defect documented by stress testing with nuclear perfusion
imaging or a wall motion abnormality determined by stress echocardiogram
* asymptomatic coronary ischemia documented by stress testing with nuclear
perfusion imaging or by stress echocardiogram
* peripheral vascular disease with symptoms of claudication and ankle brachial index
<0.9 performed by a vascular lab or angiogram (including CTA) showing <=> 50% stenosis)
* history of peripheral arterial revascularization (surgical or percutaneous) *30 days
prior to randomization
* carotid endarterectomy, carotid stenting or more than or equal to 50% stenosis in a carotid artery
determined by carotid ultrasound or angiogram *30 days prior to randomization
* history of abdominal aortic aneurysm confirmed by imaging, diagnosed *30 days prior to randomization
* ischemic stroke *30 days prior to randomization
* coronary calcium score >300 Agatston units (AU).
b. 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 following risk factors:
* chronic cigarette smoking at screening (at least 1 cigarette per day for > 1 month)
* history of hypertension (blood pressure >140/90 mm Hg) or taking antihypertensive
medication
* high-sensitivity C-reactive protein (hs-CRP) > 2.0 mg/L (19.05 nmol/L) determined
at Visit 1
* history of albuminuria (urinary albumin:creatinine ratio [ACR] >30 mg/g).
c. Male patients >50 years of age or females >60 years of age, with at least one of the
following risk factors:
* family history (mother, father or sibling) of premature coronary hea
1. Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl
esters, or corn oil.
2. Known hypersensitivity to fish and/or shellfish
3. Use of fibrates, bile acid sequestrants, or niacin or its analogues (>250 mg/day) within 4
weeks prior to Visit 2. Patients taking these agents may be considered for inclusion in the
study if these therapies have been discontinued for 4 weeks or more prior to Visit 2.However,
niacin or its analogues at a dose less than or equal to 250 mg/day is
permissible.
4. Statin naïve at Visit 1.
5. Use of simvastatin 80 mg or ezetimibe/simvastatin 10/80 mg within 4 weeks prior to Visit 2.
Patients taking these agents may be considered for inclusion in the study if these therapies
have been discontinued and replaced with a protocol acceptable statin treatment that is
stabilized for 4 weeks or more prior to Visit 2.
6. Use of any prescription medications containing eicosapentaenoic acid (EPA) and/or
docosahexaenoic acid (DHA), e.g. Lovaza® or Vascepa®, within 4 weeks prior to Visit 2.
Patients taking these agents may be considered for inclusion in the study if these therapies have been discontinued for 4 weeks or more prior to Visit 2.
7. More than one capsule/day (any dose) of omega-3 dietary
supplements. Patients taking >1 capsule/day of omega-3 supplements
before Visit 1 DO NOT require a washout period but must agree to
reduce the number of capsules per day to no more than 1 capsule of 1 g
promptly after signing the informed consent. No new omega-3
supplements are permitted following initiation of screening procedures
at Visit 1.
8. Use of prescription or over-the-counter (OTC) weight loss drugs at any time after Visit 1.
9. Chronic use of oral corticosteroids during screening (acute use for inflammation for example
from poison ivy, or intranasal or inhaled steroids for allergies/asthma, or intraarticular
injections are allowed).
10. Use of tamoxifen, estrogens, progestins, or testosterone, that has not been stable for >4
weeks at Visit 1, or is unstable prior to Visit 2.
11. Known lipoprotein lipase impairment or deficiency, or apolipoprotein C-II deficiency.
12. Hemoglobin A1c (Hb A1c) >12% at Visit 1.
13. Poorly controlled hypertension (resting blood pressure *180 mm Hg systolic and/or *100
mm Hg diastolic) at two consecutive visits prior to randomization at Visit 2.
14. Uncontrolled hypothyroidism, or thyroid stimulating hormone (TSH) >2.0 times upper limit
of normal (ULN) at Visit 1. Patients who are clinically euthyroid, on stable thyroid
replacement therapy for 2 months prior to Visit 1 are allowed.
15. History of cancer (except non-melanoma skin cancer, or carcinoma in situ of cervix) within
the previous two years.
16. Patients on dialysis.
17. Females who are pregnant, planning to be pregnant during the study period, lactating, or
women of childbearing potential who are not using an acceptable method of contraception. A
woman is considered of childbearing potential if she is not surgically sterile or if her last
menstrual period was <12 months prior to Visit 1. Acceptable methods of contraception for
this study include use of double barrier contraception, intrauterine device, all
oral, patch, etc. hormonal contraceptives as long as dose and type is stable for 3 months prior
to Visit 1. In ad
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is the time to first occurrence of any component of<br /><br>the composite of MACE: cardiovascular death, nonfatal MI, nonfatal stroke,<br /><br>emergent/elective coronary revascularization, or hospitalization for unstable<br /><br>angina. Patients will remain in the study until the required number of patients<br /><br>with MACE has occurred.</p><br>
- Secondary Outcome Measures
Name Time Method <p>KEY Secondary outcome measures include:<br /><br>* The composite measure of CV events that include the first occurrence of<br /><br>cardiovascular death, non-fatal MI, and non-fatal stroke.<br /><br>* The composite measure of coronary events that include the first occurrence of<br /><br>cardiovascular death ((including death due to acute myocardial infarction,<br /><br>sudden cardiac death and death due to cardiovascular procedures), non-fatal MI,<br /><br>emergent/elective coronary revascularization, or hospitalization for unstable<br /><br>angina.<br /><br>* Time to CV Death<br /><br><br /><br>Other Secondary outcome measures include:<br /><br>a) Emergent/elective coronary revascularization<br /><br>b) Hospitalization for unstable angina<br /><br>c) Fatal or non-fatal MI<br /><br>d) Non-fatal MI<br /><br>e) Fatal or non-fatal stroke<br /><br>f) Non-fatal stroke<br /><br>g) All-cause death</p><br>