Efficacy and Safety of Aliskiren and Valsartan Versus Placebo in Patients Stabilized Following an Acute Coronary Syndrome
Information source: Novartis
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Acute Coronary Syndrome; Myocardial Ischemia
Intervention: Aliskiren/Valsartan (Drug); Aliskiren/Valsartan (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Eugene Braunwald, MD, Study Chair, Affiliation: TIMI Study Group, Boston, MA
Overall contact:
Novartis US, Phone: 862-778-8300
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Reduction of the NT-proBNP levels for valsartan and aliskiren compared to placeboReduction of NT-proBNP levels for valsartan/aliskiren combination compared to each individual monotherapy and placebo
Secondary outcome: Reduction of adverse cardiac events rate (death, recurrent myocardial infarction, or hospitalization for congestive heart failure) as compared to placeboExplore 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 Reduction of NT-proBNP levels for valsartan or aliskiren compared to placebo Reduction of NT-proBNP levels for aliskiren or valsartan compared to placebo Reduction of levels of key biomarkers of cardiovascular risk (e.g, hsCRP, PRA) for aliskiren and valsartan combination or individual monotherapies
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 may apply.
Locations and Contacts
Novartis US, Phone: 862-778-8300
Investigative Site, Investigative Site, Belgium; Recruiting
Novartis Basel, Phone: 41 61 324 1111
Investigative Site, Investigative Site, Canada; Recruiting
Novartis , US, Phone: 862-778-8300
Investigative Site, Investigative Site, Czech Republic; Recruiting
Novartis Basel, Phone: 41 61 324 1111
Investigative Site, Investigative Site, Germany; Recruiting
Novartis Basel, Phone: 41 61 324 1111
Investigative Site, Investigative Site, Hungary; Recruiting
Novartis Basel, Phone: 41 61 324 1111
Investigative Site, Investigative Site, Netherlands; Recruiting
Novartis Basel, Phone: 41 61 324 1111
Investigative Site, Investigative Site, Poland; Recruiting
Novartis Basel, Phone: 41 61 324 1111
Investigative Site, Investigative Site, Russian Federation; Recruiting
Novartis Basel, Phone: 41 61 324 1111
Investigative Site, Investigative Site, Spain; Recruiting
Novartis Basel, Phone: 41 61 324 1111
Investigative Site, Investigative Site, Sweden; Recruiting
Novartis Basel, Phone: 41 61 324 1111
Investigative Site, Investigative Site, New Jersey, United States; Recruiting
Novartis US, Phone: 862-778-8300
Additional Information
Starting date: April 2007
Last updated: January 7, 2009
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