Clinical trial NCT00409578: Efficacy and Safety of Aliskiren and Valsartan Versus Placebo in Patients Stabilized Following an Acute Coronary Syndrome
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Acute Coronary Syndrome
Myocardial Ischemia
Keywords: Post acute coronary syndrome
Acute
coronary syndrome
B-type natriuretic peptide
N-terminal
pro-B-type natriuretic peptide
myocardial infarctions
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: The TIMI Study Group
First posted: 2006-12-11
Enrollment: 1101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8
timeFrame: Baseline to Week 8
measure: Percentage of Patients With a Cardiac Event
timeFrame: Baseline to Week 8
measure: Percentage of Patients With a Composite Clinical-biochemical Event
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Investigative Site
country: United States
facility: Investigative Site
state: New Jersey
city: Investigative Site
country: Belgium
facility: Investigative Site
city: Investigative Site
country: Canada
facility: Investigative Site
city: Investigative Site
country: Czech Republic
facility: Investigative Site
city: Investigative Site
country: Germany
facility: Investigative Site
city: Investigative Site
country: Hungary
facility: Investigative Site
city: Investigative Site
country: Netherlands
facility: Investigative Site
city: Investigative Site
country: Poland
facility: Investigative Site
city: Investigative Site
country: Russian Federation
facility: Investigative Site
city: Investigative Site
country: Spain
facility: Investigative Site
city: Investigative Site
country: Sweden
facility: Investigative Site
Study officials:
affiliation: TIMI Study Group, Boston, MA
name: Eugene Braunwald, MD
role: STUDY_CHAIR
References: