Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: Aliskiren/Valsartan
  • Aliskiren and Valsartan
• Drug: Aliskiren/Valsartan
  • Aliskiren
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Aliskiren/Valsartan
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Reduction of the NT-proBNP levels for valsartan and aliskiren compared to placebo
  • Time Frame: from baseline to week 8
    Safety Issue?: No
• Reduction of NT-proBNP levels for valsartan/aliskiren combination compared to each individual monotherapy and placebo
  • Time Frame: from baseline to week 8
    Safety Issue?: No

Secondary Measures

• Reduction of adverse cardiac events rate (death, recurrent myocardial infarction, or hospitalization for congestive heart failure) as compared to placebo
  • Time Frame: at week 8
    Safety Issue?: No
• Explore if the combination of aliskiren or valsartan reduces the rate of adverse cardiac events (death, recurrent myocardial infarction, or hospitalization for congestive heart failure) as compared to each individual monotherapy and placebo
  • Time Frame: at week 8
    Safety Issue?: No
• Reduction of NT-proBNP levels for valsartan or aliskiren compared to placebo
  • Time Frame: week 4
    Safety Issue?: No
• Reduction of NT-proBNP levels for aliskiren or valsartan compared to placebo
  • Time Frame: week 4
    Safety Issue?: No
• Reduction of levels of key biomarkers of cardiovascular risk (e.g, hsCRP, PRA) for aliskiren and valsartan combination or individual monotherapies
  • Time Frame: week 8
    Safety Issue?: No

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 may apply.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Eugene Braunwald, MD Study Chair TIMI Study Group, Boston, MA  

Overall Contact: Novartis US 862-778-8300 

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00409578

Study ID Number: CSPP100A2347

ClinicalTrials.gov Identifier: NCT00409578

Health Authority: United States: Food and Drug Administration