Phase 2
Completed N=1,101
Efficacy and Safety of Aliskiren and Valsartan Versus Placebo in Patients Stabilized Following an Acute Coronary Syndrome
Post Acute Coronary Syndrome · myocardial ischemia
Source: ClinicalTrials.gov NCT00409578 ↗
Enrolled (actual)
1,101
Serious AEs
13.2%
Results posted
Feb 2011
Primary outcomePrimary: Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8 — 0.582; 0.563; 0.614; 0.635 pg/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8 |
0.582; 0.563; 0.614; 0.635 | — |
| SECONDARY Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8 |
0.642; 0.597; 0.670; 0.682 | — |
| SECONDARY Percentage of Patients With a Cardiac Event |
2.9; 4.9; 4.9; 4.0 | — |
| SECONDARY Percentage of Patients With a Composite Clinical-biochemical Event |
79.5; 73.5; 77.2; 75.2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00409578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.