Phase 3
Completed N=820
Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)
Source: ClinicalTrials.gov NCT00414609 ↗Enrolled (actual)
820
Serious AEs
26.2%
Results posted
Jul 2011
Primary outcomePrimary: Core Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) as Measured by Echocardiography at End of Study. — -3.14; -4.13 mL
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Core Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) as Measured by Echocardiography at End of Study. |
-3.14; -4.13 | — |
| PRIMARY Extension Study: Percentage of Participants With Deaths, Serious Adverse Events (SAEs), Discontinuation for Adverse Events (AEs) and Discontinuations for Abnormal Lab Values |
4.0; 29.9; 7.1; 2.4; 5.2; 0 | — |
| SECONDARY Core Study: Time to First Occurrence for the Composite Endpoints of Echocardiogram and Adjudicated Outcomes |
6.0; 6.9; 8.6; 9.2 | — |
| SECONDARY Core Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) |
-1.37; -3.08 | — |
| SECONDARY Core Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) |
2.12; 2.24 | — |
| SECONDARY Core Study: Change From Baseline to End of Study in Infarction Segment Length (ISL) as Measured by Echocardiography |
-4.30; -5.04 | — |
| SECONDARY Core Study: Change From Baseline to End of Study in Wall Motion Score (WMS) as Measured by Echocardiography |
-0.08; -0.10 | — |
| SECONDARY Extension Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 12 |
-6.2 | — |
| SECONDARY Extension Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 12 |
6.0 | — |
| SECONDARY Extension Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 12 |
7.4 | — |
| SECONDARY Extension Study: Percentage of Participants With Orthostatic Blood Pressure Change |
2.4; 4.6; 4.1; 4.6; 3.3; 4.3 | — |
| SECONDARY Extension Study: Percentage of Participants With Specified Criteria in Selected Labs by Laboratory Parameter |
1.5; 11.2; 4.6; 4.4; 8.7 | — |
Eligibility Criteria
Core Study Inclusion Criteria:
- 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 Criteria:
- 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 5 mIU/mL)
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant Unless post-menopausal or using an acceptable method of contraception
- Any surgical or medical condition that in the opinion of the investigator may place the patient at higher risk from his/her participation in the study or was likely to prevent the patient from complying with the requirements or completing the study
Other protocol-defined inclusion/exclusion criteria applied
Data sourced from ClinicalTrials.gov (NCT00414609). 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.