NCT01042769已完成3 期
A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 7,226
- 主要终点
- Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke
研究概览
简要总结
This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Adults >18 years of age
- •Type 2 diabetes mellitus
- •Hospitalization for ACS event and randomization between hospital discharge and 8 weeks after the ACS index event (day of hospitalization)
排除标准
- •Estimated glomerular filtration rate <45 mL/min/1.73m2
- •Concomitant treatment with a thiazolidinedione and/or fibrate
- •Triglycerides >400 mg/dL
- •Symptomatic congestive heart failure classified as New York Heart Association (NYHA) class II-IV (France and Germany: Symptomatic congestive heart failure classified as NYHA class I-IV)
研究组 & 干预措施
Aleglitazar
Experimental
干预措施: Aleglitazar (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke
时间窗: Throughout study, approximately 4.5 years
次要结局
- Tolerability and long-term safety profile(Throughout study, approximately 4.5 years)
- Effects on other cardiovascular endpoints(Throughout study, approximately 4.5 years)
- Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk(Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter)
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