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

Condition(s) targeted: Post Acute Coronary Syndrome; Myocardial Ischemia

Intervention: Placebo (Drug); Aliskiren 300 mg (Drug); Valsartan 320 mg (Drug); Aliskiren/valsartan 300/320 mg (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Eugene Braunwald, MD, Study Chair, Affiliation: TIMI Study Group, Boston, MA

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.

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8

Secondary outcome:

Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8

Percentage of Patients With a Cardiac Event

Percentage of Patients With a Composite Clinical-biochemical Event

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 applied to the study.

Investigative Site, Investigative Site, Belgium

Investigative Site, Investigative Site, Canada

Investigative Site, Investigative Site, Czech Republic

Investigative Site, Investigative Site, Germany

Investigative Site, Investigative Site, Hungary

Investigative Site, Investigative Site, Netherlands

Investigative Site, Investigative Site, Poland

Investigative Site, Investigative Site, Russian Federation

Investigative Site, Investigative Site, Spain

Investigative Site, Investigative Site, Sweden

Investigative Site, Investigative Site, New Jersey, United States

Starting date: February 2007
Last updated: April 15, 2011