NCT03071692终止3 期
Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 10,544
- 试验地点
- 863
- 主要终点
- Number of Participants With First Occurrence of 4-component Composite Primary Endpoint (Nonfatal MI, Nonfatal Ischemic Stroke, Coronary Revascularization, or CV Death)
研究概览
简要总结
The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of:
- nonfatal Myocardial Infarction (MI)
- nonfatal ischemic stroke
- coronary revascularization; or
- Cardio Vascular (CV) death.
详细描述
A multi-regional clinical trial with participating sites in the following countries. India is being conducted under a previous protocol version due to regulatory requirements.
- Argentina
- Brazil
- Bulgaria
- Canada
- Colombia
- Czech Republic
- Denmark
- France
- Germany
- Hungary
- India
- Israel
- Japan
- Mexico
- Netherlands
- Poland
- Romania
- Russian Federation
- Slovakia
- South Africa
- Spain
- Ukraine
- United Kingdom
- United States
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting TG ≥ 200 mg/dL (2.26 mmol/L) and < 500 mg/dL (5.65 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
- •HDL-C ≤ 40 mg/dL (1.03 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
- •Type 2 diabetes of longer than 12 weeks duration documented in medical records, for example: local laboratory evidence through medical record review of elevated HbA1c (≥ 6.5% [48 mmol/mol]), elevated plasma glucose (fasting ≥ 126 mg/dL [7.0 mmol/L], 2-hour ≥ 200 mg/dL [11.1 mmol/L] during oral glucose tolerance testing, or random value ≥ 200 mg/dL with classic symptoms, or currently taking medication for treatment of diabetes; AND either
- •Age ≥ 50 years if male or ≥ 55 years if female (primary prevention cohort); OR
- •Age ≥ 18 years and established systemic atherosclerosis (secondary prevention cohort), defined as any 1 of the following:
- •i. Prior MI or ischemic (non-hemorrhagic) stroke
- •ii. Coronary angiographic lesion of ≥ 60% stenosis in a major epicardial vessel or ≥ 50% left main stenosis
- •iii. Asymptomatic carotid disease with ≥ 70% carotid artery stenosis
- •iv. Symptomatic carotid disease with ≥ 50% carotid artery stenosis
- •v. Symptomatic lower extremity PAD (ie, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index ≤ 0.9 or other diagnostic testing [eg, toe-brachial index, angiogram, or other imaging study])
- •vi. Prior arterial revascularization procedure (including coronary, carotid, or peripheral angioplasty/stenting, bypass, or atherectomy/endarterectomy)
排除标准
- •Current or planned use of fibrates or agents with PPAR-α agonist activity (eg, saroglitazar) within 6 weeks (42 days) of Visit 1 (Screening/Enrollment Visit). Note: PPAR-γ agonists (eg, glizatones such as pioglitazone and rosiglitazone) are allowed
- •Known sensitivity to PPAR-α agonists or tablet excipients
- •Initiation of, or change in, current TG-lowering therapy within 12 weeks of Visit 1 (if applicable). Note: TG-lowering therapy is defined as niacin > 100 mg/day or dietary supplements or prescription omega-3 fatty acids > 1 g/day
- •Type 1 diabetes mellitus
研究组 & 干预措施
Treatment Group
Experimental
K-877 (pemafibrate) tablet twice daily.
干预措施: K-877 (Drug)
Control Group
Placebo Comparator
Matching K-877 placebo tablet twice daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With First Occurrence of 4-component Composite Primary Endpoint (Nonfatal MI, Nonfatal Ischemic Stroke, Coronary Revascularization, or CV Death)
时间窗: From Baseline to a Median of 3.3 Years
Number of participants experiencing their first occurrence of any component of the 4-component composite primary endpoint, which includes nonfatal myocardial infarction (MI), nonfatal ischemic stroke, coronary revascularization, or cardiovascular (CV) death. Each participant is counted only once, regardless of any subsequent events.
次要结局
- Number of Participants With First Occurrence of the 4-component Composite Secondary Endpoint (Nonfatal MI, Nonfatal Ischemic Stroke, Hospitalization for Unstable Angina Requiring Unplanned Coronary Revascularization, or CV Death)(From Baseline to a Median of 3.3 Years)
- Number of Participants With First Occurrence of the 3-component Composite Endpoint (Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or Cardiovascular Death)(From Baseline to a Median of 3.3 Years)
- Number of Participants With First Occurrence of Any Component of the Primary Endpoint or Hospitalization for Heart Failure(From Baseline to a Median of 3.3 Years)
- Number of Participants With Occurrence of Any Component of the Primary Endpoint or All-Cause Mortality(From Baseline to a Median of 3.3 Years)
- Total Number of Events of the 4-component Composite Primary Endpoint(From Baseline to a Median of 3.3 Years)
- Number of Participants With First Occurrence of Any New or Worsening Peripheral Artery Disease (PAD)(From Baseline to a Median of 3.3 Years)
- Number of Participants With First Occurrence of Nonfatal Myocardial Infarction(From Baseline to a Median of 3.3 Years)
- Number of Participants With First Occurrence of Nonfatal Ischemic Stroke(From Baseline to a Median of 3.3 Years)
- Number of Participants With First Occurrence of Coronary Revascularization(From Baseline to a Median of 3.3 Years)
- Number of Participants With First Occurrence of Cardiovascular Death(From Baseline to a Median of 3.3 Years)
- Number of Participants With First Occurrence of the 4-component Composite Endpoint by PPAR-α Gene Variant Subgroup (TT, CT, CC)(From Baseline to a Median of 3.3 Years)
- Percent Change From Baseline to Month 4 for Total Cholesterol (TC)(Baseline to Month 4)
- Percent Change From Baseline to Month 4 for Fasting Triglycerides(Baseline to 4 Months)
- Percent Change From Baseline to Month 4 for HDL - Cholesterol (HDL-C)(Baseline to Month 4)
- Percent Change From Baseline to Month 4 for Calculated Non-HDL Cholesterol (Non-HDL-C)(Baseline to Month 4)
- Percent Change From Baseline to Month 4 for Calculated VLDL Cholesterol(Baseline to Month 4)
- Percent Change From Baseline to Month 4 for Apolipoprotein A1 (ApoA1)(Baseline to Month 4)
- Percent Change From Baseline to Month 4 for Apolipoprotein CIII (ApoC3)(Baseline to Month 4)
- Percent Change From Baseline to Month 4 for Apolipoprotein E (ApoE)(Baseline to Month 4)
- Percent Change From Baseline to Month 6 for Non-fasting Remnant Cholesterol(Baseline to Month 6)
研究者
研究点 (863)
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