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

Sponsor:	Novartis
Collaborator:	The TIMI Study Group
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00409578

Purpose

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.

Condition	Intervention	Phase
Post Acute Coronary Syndrome Myocardial Ischemia	Drug: Aliskiren/Valsartan Drug: Placebo	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

Drug Information available for: Valsartan Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Reduction of the NT-proBNP levels for valsartan and aliskiren compared to placebo [ Time Frame: from baseline to week 8 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
Reduction of NT-proBNP levels for valsartan or aliskiren compared to placebo [ Time Frame: week 4 ] [ Designated as safety issue: No ]
Reduction of NT-proBNP levels for aliskiren or valsartan compared to placebo [ Time Frame: week 4 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Enrollment:	1100
Study Start Date:	April 2007
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Aliskiren/Valsartan	Drug: Aliskiren/Valsartan Aliskiren and Valsartan Drug: Aliskiren/Valsartan Aliskiren
2: Placebo Comparator Placebo	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409578

Locations

United States, New Jersey
Investigative Site
Investigative Site, New Jersey, United States
Belgium
Investigative Site
Investigative Site, Belgium
Canada
Investigative Site
Investigative Site, Canada
Czech Republic
Investigative Site
Investigative Site, Czech Republic
Germany
Investigative Site
Investigative Site, Germany
Hungary
Investigative Site
Investigative Site, Hungary
Netherlands
Investigative Site
Investigative Site, Netherlands
Poland
Investigative Site
Investigative Site, Poland
Russian Federation
Investigative Site
Investigative Site, Russian Federation
Spain
Investigative Site
Investigative Site, Spain
Sweden
Investigative Site
Investigative Site, Sweden

Sponsors and Collaborators

Novartis

The TIMI Study Group

Investigators

Study Chair:

Eugene Braunwald, MD

TIMI Study Group, Boston, MA

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSPP100A2347
Study First Received:	December 7, 2006
Last Updated:	August 31, 2009
ClinicalTrials.gov Identifier:	NCT00409578 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Novartis:

Post acute coronary syndrome
Acute
coronary syndrome
B-type natriuretic peptide

N-terminal
pro-B-type natriuretic peptide
myocardial infarctions

Additional relevant MeSH terms:

Natriuretic Peptide, Brain
Disease
Heart Diseases
Myocardial Ischemia
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Ischemia
Antihypertensive Agents

Pharmacologic Actions
Pathologic Processes
Natriuretic Agents
Therapeutic Uses
Syndrome
Acute Coronary Syndrome
Cardiovascular Diseases
Valsartan

ClinicalTrials.gov processed this record on February 08, 2010