EUCTR2011-004726-10-PL进行中（未招募）1 期
A Multi-Center, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients with Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial) - REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 7,990
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Fasting TG levels of =200 mg/dL (2.26 mmol/L) and <500 mg/dL
- •(5.64 mmol/L).
- •2.LDL-C >40 mg/dL (1.04 mmol/L) and =100 mg/dL (2.60 mmol/L) and
- •on stable therapy with a statin (with or without ezetimibe) for at least 4
- •weeks prior to the LDL-C/TG baseline qualifying measurements for
- •randomization
- •Stable therapy is defined as the same daily dose of the same statin for
- •at least 28 days before the lipid qualification measurements (TG and
- •LDL-C) and, if applicable, the same daily dose of ezetimibe for at least 28
- •days before the lipid qualification measurements (TG and LDL-C).
- •Patients who have their statin therapy or use of ezetimibe initiated at
- •Visit 1, or have their statin, statin dose and/or ezetimibe dose changed
- •at Visit 1, will need to go through a stabilization period of at least 28
- •days since initiation/change and have their qualifying lipid
- •measurements measured (TG and LDL-C) after the washout period (at
- •Visit 1.1).
- •Statins may be administered with or without ezetimibe.
- •3.Either having established CVD (in CV Risk Category 1) or at high risk
- •for CVD (in CV Risk Category 2). The CV risk categories are defined as
- •CV Risk Category 1: defined as men and women =45 years of age with
- •one or more of the following:
- •o Documented coronary artery disease (CAD; one or more of the
- •following primary criteria must be satisfied):
- •Documented multi vessel CAD (>50% stenosis in at least two major
- •epicardial coronary arteries – with or without antecedent
- •revascularization);
- •Documented prior MI;
- •Hospitalization for high-risk non-ST-segment elevation acute coronary
- •syndrome (NSTE-ACS) (with objective evidence of ischemia: ST-segment
- •deviation or biomarker positivity).
- •o Documented cerebrovascular or carotid disease (one of the following
- •primary criteria must be satisfied):
- •Documented prior ischemic stroke;
- •Symptomatic carotid artery disease with =50% carotid arterial
- •Asymptomatic carotid artery disease with =70% carotid arterial
- •stenosis per angiography or duplex ultrasound;
- •History of carotid revascularization (catheter-based or surgical).
- •o Documented peripheral arterial disease (PAD; one or more of the
- •following primary criteria must be satisfied):
- •Ankle-brachial index (ABI) <0.9 with symptoms of intermittent
- •claudication;
- •History of aorto-iliac or peripheral arterial intervention (catheter-based
- •or surgical).
- •CV Risk Category 2: defined as patients with:
- •1.Diabetes mellitus (Type 1 or Type 2) requiring treatment with
- •medication AND
- •2.Men and women =50 years of age AND
- •3. One of the following at Visit 1 (additional risk factor for CVD):
- •Men =55 years of age and Women =65 years of age;
- •Cigarette smoker or stopped smoking within 3 months before Visit 1;
- 另有 14 项未显示
排除标准
- •1. Severe (New York Heart Association [NYHA] class IV) heart failure.
- •2. Any life-threatening disease expected to result in death within the
- •next 2 years (other than CVD).
- •3. Active severe liver disease (evaluated at Visit 1): cirrhosis, active
- •hepatitis, alanine aminotransferase (ALT) or aspartate aminotransferase
- •(AST) >3 × the upper limit of normal (ULN), or biliary obstruction with
- •hyperbilirubinemia (total bilirubin >2 × ULN).
- •4. Hemoglobin A1c (HbA1c ) >10.0% (or >86 mmol/mol International
- •Federation of Clinical Chemistry [IFCC] units) at screening (Visit 1). If
- •patients fail this criterion (HbA1c >10.0% or >86 mmol/mol IFCC units)
- •at Visit 1, they may have their antidiabetic therapy optimized and be
- •retested at Visit 1.1.
- •5.Poorly controlled hypertension: blood pressure =200 systolic mmHg
- •OR =100 mmHg diastolic (despite antihypertensive therapy).
- •6.Planned coronary intervention (such as stent placement or heart
- •bypass) or any non-cardiac major surgical procedure. Patients can be
- •(re)evaluated for participation in the trial (starting with Visit 1.1) after
- •their recovery from the intervention/surgery.
- •7.Known familial lipoprotein lipase deficiency (Fredrickson Type I),
- •apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia
- •(Fredrickson Type III).
- •8.Participation in another clinical trial involving an investigational agent
- •within 90 days prior to screening (Visit 1). Patients cannot participate in
- •any other investigational medication or medical device trial while
- •participating in this study (participation in a registry or observational
- •study without additional therapeutic intervention is allowed).
- •9.Intolerance or hypersensitivity to statin therapy.
- •10.Known hypersensitivity to any ingredients of the study product or
- •placebo (refer to Table 5); known hypersensitivity to fish and or
- •11.History of acute or chronic pancreatitis.
- •12.Malabsorption syndrome and/or chronic diarrhea. (Note: patients
- •who have undergone gastric/intestinal bypass surgery are considered to
- •have malabsorption, hence are excluded; patients who have undergone
- •gastric banding are allowed to enter the trial).
- •13. Non-study drug related, non-statin, lipid-altering medications,
- •supplements or foods:
- •Patients are excluded if they used niacin >200 mg/day or fibrates
- •during the screening period (after Visit 1) and/or plan to use during the
- •study; patients who are taking niacin >200 mg/day or fibrates during
- •the last 28 days before Visit 1 need to go through washout of at least 28
- •days after their last use and have their qualifying lipids measured (TG
- •and LDL-C) after the washout period (Visit 1.1);
- •Patients are excluded if they take any omega-3 fatty acid medications
- •(prescription medicines containing EPA and/or docosahexaenoic acid
- •[DHA]) during the screening period (after Visit 1) and/or plan to use
- •during the treatment/follow-up period of the study. To be eligible for
- •participation in the study, patients who are taking omega-3 fatty acid
- •medications during the last 28 days before Visit 1 (except patients in the
- •Netherlands), need to go through a washout period of at least 28 days
- •after their last use and have their qualifying lipid measurements
- 另有 5 项未显示
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