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

ovartis Pharma Services AG0 个研究点目标入组 1,100 人开始时间: 2007年1月24日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Subjects who are hospitalized for ischemic chest discomfort at rest lasting at
•least 10 minutes and consistent with cardiac ischemia
•Subjects who are clinically stable may not have any of the following spontaneous
•events for 24 hours prior to randomization:
•Recurrent ischemia at rest
•Symptomatic hypotension or hypotension defined as SBP < 90 mmHg
•Acute mitral regurgitation
•Acute ventricular septal defect
•Ventricular fibrillation
•Sustained ventricular tachycardia (>30 seconds)
•Complete heart block
•High grade second degree heart block (e.g. Mobitz Type II)
•New onset atrial fibrillation
•2. Final diagnosis of acute coronary syndrome that includes either:
•unstable angina defined as chest discomfort with 1) transient ST segment
•deviation at least 0.5 mm in at least two contiguous leads or, 2) documented
•coronary artery disease as defined as prior MI or evidence of a coronary
•stenosis at least 50% or
•acute myocardial infarction (MI) defined as elevated concentrations of cardiac
•troponin I or T, or CK-MB
•3. Elevated concentrations of natriuretic peptide (local determination) 3-10 days
•(72 -240 hours) after admission for their index event
•NT-proBNP level > 400 pg/ml or BNP level > 80 pg/ml
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•For full list, refer to protocol
•1. Known or suspected contraindications, including history of allergy or
•hypersensitivity to ARBs, renin antagonists, or to drugs with similar chemical
•structures.
•2. Presence of clinically overt heart failure defined as the presence of rales 1/3 up
•both lung fields, chest radiography showing at least moderate pulmonary
•venous congestion, or the presence of a third heart sound.
•3. Known evidence of left ventricular systolic dysfunction (an ejection fraction <=
•40% as determined by echocardiography, nuclear imaging or ventriculography).
•4. CABG less than 3 months before randomization.
•5. PCI less than 24 hours before randomization.
•6. Planned revascularization within 3 months after randomization.
•7. Patients on chronic ACEI or ARB therapy for whom therapy with an ACEI or ARB is
•clinically required with no reasonable alternative therapy available
•8. Estimated creatinine clearance <45 ml/min (Cockroft Gault Formula) or GFR
•<45 ml/min/1.73 m² (MDRD Calculation)

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