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

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

MedlinePlus related topics:

Heart Attack

Drug Information available for:

Valsartan Nesiritide Aliskiren Proline

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	1100
Study Start Date:	April 2007
Estimated Primary Completion Date:	June 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

Contacts


Contact: Novartis US	862-778-8300

Contact: Novartis Basel	41-61-324-1111

Locations


United States, New Jersey
	Investigative Site	Recruiting
	Investigative Site, New Jersey, United States
	Contact: Novartis US 862-778-8300

Belgium
	Investigative Site	Recruiting
	Investigative Site, Belgium
	Contact: Novartis Basel 41 61 324 1111

Canada
	Investigative Site	Recruiting
	Investigative Site, Canada
	Contact: Novartis , US 862-778-8300

Czech Republic
	Investigative Site	Recruiting
	Investigative Site, Czech Republic
	Contact: Novartis Basel 41 61 324 1111

Germany
	Investigative Site	Recruiting
	Investigative Site, Germany
	Contact: Novartis Basel 41 61 324 1111

Hungary
	Investigative Site	Recruiting
	Investigative Site, Hungary
	Contact: Novartis Basel 41 61 324 1111

Netherlands
	Investigative Site	Recruiting
	Investigative Site, Netherlands
	Contact: Novartis Basel 41 61 324 1111

Poland
	Investigative Site	Recruiting
	Investigative Site, Poland
	Contact: Novartis Basel 41 61 324 1111

Russian Federation
	Investigative Site	Recruiting
	Investigative Site, Russian Federation
	Contact: Novartis Basel 41 61 324 1111

Spain
	Investigative Site	Recruiting
	Investigative Site, Spain
	Contact: Novartis Basel 41 61 324 1111

Sweden
	Investigative Site	Recruiting
	Investigative Site, Sweden
	Contact: Novartis Basel 41 61 324 1111

Sponsors and Collaborators

Novartis

The TIMI Study Group

Investigators


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

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSPP100A2347
First Received:	December 7, 2006
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00409578
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

Study placed in the following topic categories:

Natriuretic Peptide, Brain

Heart Diseases

Myocardial Ischemia

Acute Coronary Syndrome

Vascular Diseases

Ischemia

Infarction

Myocardial Infarction

Valsartan

Additional relevant MeSH terms:

Disease

Pathologic Processes

Natriuretic Agents

Therapeutic Uses

Syndrome

Physiological Effects of Drugs

Cardiovascular Diseases

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2008

Sponsors and Collaborators:	Novartis The TIMI Study Group
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00409578