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

Novartis

Status and phase: Completed; Phase 2

Conditions: Myocardial Ischemia; Post Acute Coronary Syndrome

Treatments: Drug: Valsartan 320 mg; Drug: Aliskiren 300 mg; Drug: Placebo; Drug: Aliskiren/valsartan 300/320 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00409578

CSPP100A2347

Details and patient eligibility

About

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.

Enrollment: 1,101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,101 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo tablets and capsules

Treatment:

Drug: Placebo

Aliskiren 300 mg

Experimental group

Description:

Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.

Treatment:

Drug: Aliskiren 300 mg

Valsartan 320 mg

Experimental group

Description:

Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.

Treatment:

Drug: Valsartan 320 mg

Aliskiren/valsartan 300/320 mg

Experimental group

Description:

Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.

Treatment:

Drug: Aliskiren/valsartan 300/320 mg