Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)
5. července 2012 aktualizováno: Novartis
A 36-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Including a 2 Year Extension Study to Evaluate Efficacy and Safety of Aliskiren on the Prevention of Left Ventricular Remodeling in High Risk Post-acute Myocardial Infarction Patients When Added to Optimized Standard Therapy
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).
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
820
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Novartis Argentina, Argentina
- Novartis Argentina
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Novartis Belgium, Belgie
- Novartis Belgium
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Novartis Denmark, Dánsko
- Novartis Denmark
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Novartis Netherlands, Holandsko
- Novartis Netherlands
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Worli, Mumbai, Indie, 400018
- Novartis Healthcare Private Limited
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Novartis Italy, Itálie
- Novartis Italy
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Petach Tikva, Izrael, IL-49250
- Novartis Pharma
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Novartis Canada, Kanada
- Novartis CANADA
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Bogota, Kolumbie
- Novartis de Colombia S.A.
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Seoul, Korejská republika, 100-803
- Novartis Korea Ltd.
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Istanbul, Krocan, TR-34353
- Novartis Turkey
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Budapest, Maďarsko, H-1537
- Novartis Hungary
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Novartis Norway, Norsko
- Novartis Norway
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Novartis Germany, Německo
- Novartis Germany
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Warszawa, Polsko, PL-00-710-
- Novartis Poland Sp. z o.o.
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Novartis Russia, Ruská Federace
- Novartis Russia
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Bratislava, Slovensko, SK-821 09
- Novartis Slovakia
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Novartis, Spojené království
- Novartis UK
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New Jersey
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Novartis US, New Jersey, Spojené státy
- Novartis US
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Caracas, Venezuela, 1062
- Novartis de Venezuela, S.A.
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Praha 3
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Praha, Praha 3, Česká republika, CZ-130 00
- Novartis Czech Republic
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Novartis Spain, Španělsko
- Novartis Spain
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Novartis Sweden, Švédsko
- Novartis Sweden
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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 was available in 75 mg tablet, 150 mg tablet
Ostatní jména:
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Komparátor placeba: placebo
Core study: placebo for 36 weeks once daily in the morning
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Placebo tablets matching aliskiren for 36 weeks once daily in the morning for core period only.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Core Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) as Measured by Echocardiography at End of Study.
Časové okno: Baseline and final visit (after 26 to 36 weeks of treatment)
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Change from baseline to end of study in left ventricular end systolic volume (LVESV) as measured by echocardiography.
LVESV is a measurement of the volume of blood in the heart's left ventricular chamber at the end of the heart's contraction.
This measurement was made by the echocardiography lab.
LVESV values between 22 to 58 mL for men and 19-49 mL for women are considered normal.
Baseline LVESV was a covariate.
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Baseline and final visit (after 26 to 36 weeks of treatment)
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Extension Study: Percentage of Participants With Deaths, Serious Adverse Events (SAEs), Discontinuation for Adverse Events (AEs) and Discontinuations for Abnormal Lab Values
Časové okno: Extension study (24 weeks)
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AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.
Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
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Extension study (24 weeks)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Core Study: Time to First Occurrence for the Composite Endpoints of Echocardiogram and Adjudicated Outcomes
Časové okno: LVEF was measured at baseline and at final visit (after 26 to 36 weeks of treatment). Other endpoint components were assessed from randomization until the end of the study (week 36).
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Composite outcome 1 included: Cardiovascular (CV) Death, hospitalization for heart failure (HF), or absolute reduction in Left Ventricular Ejection Fraction (LVEF) greater than 6%.
Composite outcome 2 included: CV Death, hospitalization for HF, recurrent Myocardial Infarction, Stroke, or Resuscitated Sudden Death.
LVEF was measured at baseline and final visit.
All other events were adjudicated by a blinded external committee.
Each composite endpoint analysis was based on (a) the percent of patients with that endpoint and (b) days in study to 1st event (or last exposure if no event occurred).
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LVEF was measured at baseline and at final visit (after 26 to 36 weeks of treatment). Other endpoint components were assessed from randomization until the end of the study (week 36).
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Core Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV)
Časové okno: Baseline and final visit (after 26 to 36 weeks of treatment)
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Change from baseline to end of study in left ventricular end diastolic volume (LVEDV) as measured by echocardiography.
(LVEDV) is a measurement of the volume of blood in the heart's left ventricular chamber at the beginning of the chamber's filling with blood.
This measurement was made by the echocardiography lab.
LVEDV values between 67 to 155 mL for men and 56 to 104 mL for women are considered normal.
Baseline LVEDV was a covariate.
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Baseline and final visit (after 26 to 36 weeks of treatment)
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Core Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Časové okno: Baseline and final visit (after 26 to 36 weeks of treatment )
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Change from baseline to end of study in left ventricular ejection fraction (LVEF) (%) as measured by echocardiography.
LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart.
This measurement was made by the echocardiography lab.
Ejection fraction percentages > 55% are considered normal.
Baseline LVEF was a covariate.
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Baseline and final visit (after 26 to 36 weeks of treatment )
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Core Study: Change From Baseline to End of Study in Infarction Segment Length (ISL) as Measured by Echocardiography
Časové okno: Baseline and final visit (after 26 to 36 weeks of treatment)
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Change from baseline to end of study in infarction segment length (ISL) (%) as measured by echocardiography.
This is the length of the myocardial infarction segment as a percentage of the total cavity perimeter length as calculated by the echocardiography lab.
Baseline ISL was a covariate.
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Baseline and final visit (after 26 to 36 weeks of treatment)
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Core Study: Change From Baseline to End of Study in Wall Motion Score (WMS) as Measured by Echocardiography
Časové okno: Baseline and final visit (after 26 to 36 weeks of treatment)
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Change from baseline to end of study in Wall Motion Score (WMS) as measured by echocardiography.
WMS was obtained by examining multiple segments of the left ventricle and assigning each segment a score based on myocardial thickening: 1 for normal, 2 for hypokinetic; 3 for akinetic; and 4 for dyskinetic.
The WMS was obtained as the average score for the segments visualized and was calculated by the echocardiography lab.
Possible values range from 1 to 5. Higher scores are considered worse.
Baseline WMS was a covariate.
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Baseline and final visit (after 26 to 36 weeks of treatment)
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Extension Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 12
Časové okno: Baseline(extension study), Month 12 (extension study)
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Change from baseline to Month 12 in left ventricular end systolic volume (LVESV) as measured by echocardiography.
LVESV is a measurement of the volume of blood in the heart's left ventricular chamber at the end of the heart's contraction.
This measurement was made by the echocardiography lab.
LVESV values between 22 to 58 mL for men and 19-49 mL for women are considered normal.
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Baseline(extension study), Month 12 (extension study)
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Extension Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 12
Časové okno: Baseline (extension study), Month 12 (extension study)
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Change from baseline to Month 12 in left ventricular end diastolic volume (LVEDV) as measured by echocardiography.
LVEDV is a measurement of the volume of blood in the heart's left ventricular chamber at the beginning of the chamber's filling with blood.
This measurement was made by the echocardiography lab.
LVEDV values between 67 to 155 mL for men and 56 to 104 mL for women are considered normal.
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Baseline (extension study), Month 12 (extension study)
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Extension Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 12
Časové okno: Baseline(extension study), Month 12 (extension study)
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Change from baseline to Month 12 in left ventricular ejection fraction (LVEF) (%) as measured by echocardiography.
LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart.
This measurement was made by the echocardiography lab.
Ejection fraction percentages > 55% are considered normal.
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Baseline(extension study), Month 12 (extension study)
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Extension Study: Percentage of Participants With Orthostatic Blood Pressure Change
Časové okno: Baseline (Day 0 Extension study), Week 2, Months 1, 3, 6, 9,16, 20, 24
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Orthostatic blood pressure change is defined as a decrease of at least 20 mmHg in systolic blood pressure or a decrease of at least 10 mmHg in diastolic blood pressure when a patient moves from a sitting position to a standing position.
A patient could show orthostatic blood pressure change at more than one visit.
End of study is Month 24 or early discontinuation.
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Baseline (Day 0 Extension study), Week 2, Months 1, 3, 6, 9,16, 20, 24
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Extension Study: Percentage of Participants With Specified Criteria in Selected Labs by Laboratory Parameter
Časové okno: 24 Months
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Fasting blood samples were collected throughout the study and were analyzed at a central laboratory. Percentage of participants with the following clinically significant laboratory values are reported: Potassium <3.5 mmol/L; Low value (Normal reference range: 3.5- 5.3) Potassium >5.5 mmol/L and Potassium >6.0 mmol/L; High values (Normal reference range: 3.5-5.3) Creatinine >176.8 μmol/L; High value (Normal reference range= Male: 62- 106 and Female 44- 80) Blood Urea Nitrogen (BUN) >14.28; High value (Normal reference range: 2.1- 8.9) |
24 Months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Studijní židle: Novartis US, Novartis
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. prosince 2006
Primární dokončení (Aktuální)
1. září 2009
Dokončení studie (Aktuální)
1. července 2011
Termíny zápisu do studia
První předloženo
19. prosince 2006
První předloženo, které splnilo kritéria kontroly kvality
20. prosince 2006
První zveřejněno (Odhad)
21. prosince 2006
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
13. července 2012
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
5. července 2012
Naposledy ověřeno
1. července 2012
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CSPP100A2340
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .