Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)
NCT ID: NCT00414609
Last Updated: 2012-07-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
820 participants
INTERVENTIONAL
2006-12-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aliskiren
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.
Aliskiren
Aliskiren was available in 75 mg tablet, 150 mg tablet
placebo
Core study: placebo for 36 weeks once daily in the morning
placebo
Placebo tablets matching aliskiren for 36 weeks once daily in the morning for core period only.
Interventions
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Aliskiren
Aliskiren was available in 75 mg tablet, 150 mg tablet
placebo
Placebo tablets matching aliskiren for 36 weeks once daily in the morning for core period only.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
* 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)
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis US
Role: STUDY_CHAIR
Novartis
Locations
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Novartis US
Novartis US, New Jersey, United States
Novartis Argentina
Novartis Argentina, , Argentina
Novartis Belgium
Novartis Belgium, , Belgium
Novartis Canada
Novartis Canada, , Canada
Novartis de Colombia S.A.
Bogotá, , Colombia
Novartis Czech Republic
Prague, Praha 3, Czechia
Novartis Denmark
Novartis Denmark, , Denmark
Novartis Germany
Novartis Germany, , Germany
Novartis Hungary
Budapest, Budapest, Hungary
Novartis Healthcare Private Limited
Worli, Mumbai, , India
Novartis Pharma
Petah Tikva, Petach Tikva, Israel
Novartis Italy
Novartis Italy, , Italy
Novartis Netherlands
Novartis Netherlands, , Netherlands
Novartis Norway
Novartis Norway, , Norway
Novartis Poland Sp. z o.o.
Warsaw, , Poland
Novartis Russia
Novartis Russia, , Russia
Novartis Slovakia
Bratislava, Bratislava Region, Slovakia
Novartis Korea Ltd.
Seoul, Seoul, South Korea
Novartis Spain
Novartis Spain, , Spain
Novartis Sweden
Novartis Sweden, , Sweden
Novartis Turkey
Istanbul, Istanbul, Turkey (Türkiye)
Novartis UK
Novartis, , United Kingdom
Novartis de Venezuela, S.A.
Caracas, , Venezuela
Countries
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References
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Solomon SD, Shin SH, Shah A, Skali H, Desai A, Kober L, Maggioni AP, Rouleau JL, Kelly RY, Hester A, McMurray JJ, Pfeffer MA; Aliskiren Study in Post-MI Patients to Reduce Remodeling (ASPIRE) Investigators. Effect of the direct renin inhibitor aliskiren on left ventricular remodelling following myocardial infarction with systolic dysfunction. Eur Heart J. 2011 May;32(10):1227-34. doi: 10.1093/eurheartj/ehq522. Epub 2011 Feb 10.
Other Identifiers
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CSPP100A2340
Identifier Type: -
Identifier Source: org_study_id
NCT00699075
Identifier Type: -
Identifier Source: nct_alias