Status:
COMPLETED
Efficacy and Safety of Aliskiren and Valsartan Versus Placebo in Patients Stabilized Following an Acute Coronary Syndrome
Lead Sponsor:
Novartis
Collaborating Sponsors:
The TIMI Study Group
Conditions:
Post Acute Coronary Syndrome
Myocardial Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 alisk...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
1101 Patients enrolled
Trial Details
Trial ID
NCT00409578
Start Date
February 1 2007
End Date
April 1 2009
Last Update
April 19 2011
Active Locations (11)
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1
Investigative Site
Investigative Site, New Jersey, United States
2
Investigative Site
Investigative Site, Belgium
3
Investigative Site
Investigative Site, Canada
4
Investigative Site
Investigative Site, Czechia