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

Completed · Phase 2 · Has a placebo group

Conditions studied: Post Acute Coronary Syndrome, Myocardial Ischemia

In brief

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.

Key facts

Study ID

NCT00409578

Run by

Novartis

People needed

1101

Starts

2007-02-01

Expected to finish

2009-04-01

Last updated by the study team

2011-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Investigative Site — Investigative Site, New Jersey, United States
• Investigative Site — Investigative Site, Belgium
• Investigative Site — Investigative Site, Canada
• Investigative Site — Investigative Site, Czechia
• Investigative Site — Investigative Site, Germany
• Investigative Site — Investigative Site, Hungary
• Investigative Site — Investigative Site, Netherlands
• Investigative Site — Investigative Site, Poland
• Investigative Site — Investigative Site, Russia
• Investigative Site — Investigative Site, Spain
• Investigative Site — Investigative Site, Sweden

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.