A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multinational Clinical Trial to Evaluate the Efficacy of Aliskiren and Valsartan Versus Placebo in Lowering Levels on NT-proBNP in Stabilized Patients Post Acute Coronary Syndromes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 1,101
- 试验地点
- 1
- 主要终点
- Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8
研究概览
简要总结
The purpose of this study is to test the hypothesis that the inhibition of the renin-angiotensin-aldosterone system (RAAS) with the angiotensin receptor blocker valsartan or the renin antagonist aliskiren will improve ventricular hemodynamics, as reflected by a greater reduction in levels of N-terminal proB-type natriuretic peptide (NT-proBNP) compared to placebo in subjects stabilized following acute coronary syndrome (ACS) who are determined to be at high risk due to an elevated concentration of natriuretic peptides.
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
- Triple (Participant, 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
- •Male or female outpatients 18 years old or older
- •Subjects who are hospitalized for ischemic chest discomfort at rest lasting at least 10 minutes and consistent with cardiac ischemia
- •Final diagnosis of acute coronary syndrome
- •Elevated concentrations of natriuretic peptide 3-10 days after admission for their qualifying acute coronary syndrome event
排除标准
- •Known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin receptor blockers (ARBs), renin antagonists, or to drugs with similar chemical structures.
- •Presence of clinically overt heart failure
- •Known evidence of left ventricular systolic dysfunction
- •Percutaneous coronary intervention (PCI) less than 24 hours before randomization.
- •Patients on chronic ACEI or ARB therapy for whom therapy with an ACEI or ARB is clinically required with no reasonable alternative therapy available.
- •Other protocol-defined inclusion/exclusion criteria applied to the study.
研究组 & 干预措施
Placebo
Placebo tablets and capsules
干预措施: Placebo (Drug)
Aliskiren 300 mg
Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
干预措施: Aliskiren 300 mg (Drug)
Valsartan 320 mg
Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
干预措施: Valsartan 320 mg (Drug)
Aliskiren/valsartan 300/320 mg
Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
干预措施: Aliskiren/valsartan 300/320 mg (Drug)
结局指标
主要结局
Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8
时间窗: Baseline to Week 8
Blood samples for the measurement of NT-proBNP were collected, processed, and shipped to the TIMI Biomarker Core Laboratory, Boston MA for storage and analysis. The change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.
次要结局
- Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8(Baseline to Week 8)
- Percentage of Patients With a Cardiac Event(Baseline to Week 8)
- Percentage of Patients With a Composite Clinical-biochemical Event(Baseline to Week 8)