Efficacy and Safety of Aliskiren and Valsartan Versus Placebo in Patients Stabilized Following an Acute Coronary Syndrome
Post Acute Coronary Syndrome, Myocardial Ischemia
About this trial
This is an interventional treatment trial for Post Acute Coronary Syndrome focused on measuring Post acute coronary syndrome, Acute, coronary syndrome, B-type natriuretic peptide, N-terminal, pro-B-type natriuretic peptide, myocardial infarctions
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
Placebo
Aliskiren 300 mg
Valsartan 320 mg
Aliskiren/valsartan 300/320 mg
Placebo tablets and capsules
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.
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.
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.