Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)

Novartis

Status and phase: Completed; Phase 3

Conditions: Myocardial Infarction

Treatments: Drug: Aliskiren; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00414609

CSPP100A2340

Details and patient eligibility

About

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).

Enrollment: 820 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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820 participants in 2 patient groups, including a placebo group

Aliskiren

Experimental group

Description:

Core Study: Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for next 34 weeks orally once daily in the morning. Extension Study: Patients from both the core arms who completed core study and signed informed consent form were included in this arm of extension study. Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study.

Treatment:

Drug: Aliskiren

placebo

Placebo Comparator group

Description:

Core study: placebo for 36 weeks once daily in the morning

Treatment:

Drug: placebo