Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: Aliskiren; placebo
Intervention description: Aliskiren was available in 75 mg tablet, 150 mg tablet; Placebo tablets matching aliskiren for 36 weeks once daily in the morning for core period only.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 820.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: myocardial infarction, aliskiren, heart failure; Post acute myocardial infarction with systolic dysfunction

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:

        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 < 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 Exclusion Criteria:

          -  New York Heart Association (NYHA) class IV Congestive Heart Failure at Visit 1 (Core
             study Visit 10)

          -  Symptomatic hypotension or reported systolic blood pressure (BP) < 90 mmHg within 24
             hours prior to Visit 1 (Core study Visit 10)

          -  Known Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73m^2 using the
             Modification of Diet in Renal Disease (MDRD) formula at Visit 1 (Core study Visit 10)

          -  Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive hCG laboratory test (> 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