Conditions: Myocardial Infarction
Keywords: myocardial infarction, aliskiren, heart failure Post acute myocardial infarction with systolic dysfunction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 820
Healthy volunteers: no

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).

Detailed description:

Arms:
arm 1: 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. arm 2: Core study: placebo for 36 weeks once daily in the morning

Interventions: intervention 1: Aliskiren intervention 2: placebo
Intervention descriptions: intervention 1: Aliskiren was available in 75 mg tablet, 150 mg tablet intervention 2: Placebo tablets matching aliskiren for 36 weeks once daily in the morning for core period only.

Protocol document: