Status:
COMPLETED
Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)
Lead Sponsor:
Novartis
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The core and extension studies assessed the safety and efficacy of aliskiren when added to optimized standard therapy in patients that have had a high risk acute myocardial infarction (heart attack).
Eligibility Criteria
Inclusion
- Core Study
- Male or female patients 18 years and older.
- Patients within 7-42 days of an acute myocardial infarction associated with left ventricular systolic dysfunction.
- Documented left ventricular systolic dysfunction associated with the qualifying acute myocardial.
- Patients must be on stable doses of the following concomitant medications for at least 2 weeks prior to Visit 1 unless contraindicated due to intolerance:
- A Beta-blocker
- An Anti-platelet agent
- A Statin
- An evidence-based dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) but not both.
- Qualifying Echocardiogram at Visit 1:
- Core Study
Exclusion
- Patients requiring both Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin Receptor Blocker (ARB) combination therapy at V1 or any time during the study.
- Severe refractory hypertension defined as mean sitting systolic blood pressure (MSSBP) ≥ 180 mmHg and/or mean sitting diastolic blood pressure (MSDBP) ≥ 110 mmHg) at Visit 2.
- Cardiogenic shock or systolic BP \< 100 mmHg or diastolic \< 60 mmHg within the 24 hours prior to Visits 1 or 2
- Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73m2 using the MDRD formula at Visit 1.
- Stroke or transient ischemic event (TIA) within 6 months of Study Visit 1
- Extension Study Inclusion Criteria:
- Male or female patients who completed the core study through Visit 10 while on double-blind study drug
- Patients who were able to participate in the study, and who consented to do so after the purpose and nature of the study had been clearly explained to them (written informed consent)
- Extension Study
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
820 Patients enrolled
Trial Details
Trial ID
NCT00414609
Start Date
December 1 2006
End Date
July 1 2011
Last Update
July 13 2012
Active Locations (23)
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1
Novartis US
Novartis US, New Jersey, United States
2
Novartis Argentina
Novartis Argentina, Argentina
3
Novartis Belgium
Novartis Belgium, Belgium
4
Novartis Canada
Novartis Canada, Canada