Efficacy and Safety of Aliskiren and Valsartan Versus Placebo in Patients Stabilized Following an Acute Coronary Syndrome
Condition: Post Acute Coronary Syndrome; Myocardial Ischemia
MeSH terms: Acute Coronary Syndrome; Myocardial Ischemia; Syndrome; Ischemia
Intervention: Placebo; Aliskiren 300 mg; Valsartan 320 mg; Aliskiren/valsartan 300/320 mg
Intervention description: Placebo tablets and capsules. In order to adequately blind the study, patients were required to take a total of 1 tablet and 2 capsules during the first 4 weeks of the study. During the remainder of the study, patients were required to take 2 tablets and 2 capsules. Each dose was taken by mouth with water at approximately 8:00 AM with or without food.; 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. If a patient was not up-titrated or required down-titration, the patient continued on that dose for the remainder of the study. If 2 down-titrations were required, they stopped study drug. In order to adequately blind the study, patients were required to take 1 tablet and 2 capsules during the first 4 weeks of the study and 2 tablets and 2 capsules for the remainder of the study. Each dose was taken by mouth with water at approximately 8:00 AM.; 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. If a patient was not up-titrated or required down-titration, the patient continued on that dose for the remainder of the study. If 2 down-titrations were required, they stopped study drug. In order to adequately blind the study, patients were required to take 1 tablet and 2 capsules during the first 4 weeks of the study and 2 tablets and 2 capsules for the remainder of the study. Each dose was taken by mouth with water at approximately 8:00 AM.; 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. If a patient was not up-titrated or required down-titration, the patient continued on that dose for the remainder of the study. If 2 down-titrations were required, they stopped study drug. In order to adequately blind the study, patients were required to take 1 tablet and 2 capsules during the first 4 weeks of the study and 2 tablets and 2 capsules for the remainder of the study. Each dose was taken by mouth with water at approximately 8:00 AM.
Intervention MeSH terms: Valsartan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post acute coronary syndrome; Acute; coronary syndrome; B-type natriuretic peptide; N-terminal; pro-B-type natriuretic peptide; myocardial infarctions

Summary:

      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.
    

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.