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

Phase 2

Completed

• Conditions: acute coronary syndrome = heart attack; chest pain; 10047075

• Registration Number: NL-OMON30304
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

For complete list, please refer to the protocol;- Stable 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, that includes either 1) unstable angina defined as chest discomfort or 2) acute myocardial infarction
- Elevated concentrations of natriuretic peptide 3-10 days after admission for their qualifying ACS event

Exclusion Criteria

- Known or suspected contraindications, including history of allergy or hypersensitivity to ARBs, renin antagonists, or to drugs with similar chemical structures
- Presence of clinically overt heart failure
- Known evidence of left ventricular systolic dysfunction
- CABG less than 3 months ago
- PCI less than 24 hours before randomization
- Planned revascularisation within 2 months after randomization
- New ACEI, ARBs, or aldosterone inhibitor treatment given for more than 24 hours as part of the index hospitalization
- An increase in a chronic dose of ACEI, ARBs, or aldosterone inhibitor treatment given for more than 24 hours as part of the index hospitalization
- Patients on chronic ACEI or ARB therapy for whom therapy with an ACEI or ARB is clinically required with no reasonable alternative therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Relative reduction to baseline in NT-proBNP at week 8</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Relative reduction to baseline in NT-proBNP at week 4<br /><br>Cardiac events<br /><br>Safety (AEs, safety laboratory)<br /><br>Biomarkers (a.m. high sensitivity C-reactive protein; plasma renin activity;<br /><br>aldosterone; refer to protocol, page 59, Biomarkers, for complete list)</p><br>