Efficacy and Safety of Aliskiren and Valsartan Versus Placebo in Patients Stabilized Following an Acute Coronary Syndrome

Last updated: April 15, 2011
Sponsor: Novartis
Overall Status: Completed

Phase

2

Condition

Vascular Diseases

Myocardial Ischemia

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT00409578
CSPP100A2347
  • Ages > 18
  • All Genders

Study 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

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 theirqualifying acute coronary syndrome event

Exclusion

Exclusion Criteria:

  • Known or suspected contraindications, including history of allergy or hypersensitivityto angiotensin receptor blockers (ARBs), renin antagonists, or to drugs with similarchemical 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 isclinically required with no reasonable alternative therapy available. Other protocol-defined inclusion/exclusion criteria applied to the study.

Study Design

Total Participants: 1101
Study Start date:
February 01, 2007
Estimated Completion Date:
April 30, 2009

Connect with a study center

  • Investigative Site

    Investigative Site,
    Belgium

    Site Not Available

  • Investigative Site

    Investigative Site,
    Canada

    Site Not Available

  • Investigative Site

    Investigative Site,
    Czech Republic

    Site Not Available

  • Investigative Site

    Investigative Site,
    Germany

    Site Not Available

  • Investigative Site

    Investigative Site,
    Hungary

    Site Not Available

  • Investigative Site

    Investigative Site,
    Netherlands

    Site Not Available

  • Investigative Site

    Investigative Site,
    Poland

    Site Not Available

  • Investigative Site

    Investigative Site,
    Russian Federation

    Site Not Available

  • Investigative Site

    Investigative Site,
    Spain

    Site Not Available

  • Investigative Site

    Investigative Site,
    Sweden

    Site Not Available

  • Investigative Site

    Investigative Site, New Jersey
    United States

    Site Not Available

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