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

5. juli 2012 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

820

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Novartis Argentina, Argentina
        • Novartis Argentina
  • Belgien
      • Novartis Belgium, Belgien
        • Novartis Belgium
  • Canada
      • Novartis Canada, Canada
        • Novartis CANADA
  • Colombia
      • Bogota, Colombia
        • Novartis de Colombia S.A.
  • Danmark
      • Novartis Denmark, Danmark
        • Novartis Denmark
  • Den Russiske Føderation
      • Novartis Russia, Den Russiske Føderation
        • Novartis Russia
  • Det Forenede Kongerige
      • Novartis, Det Forenede Kongerige
        • Novartis UK
  • Forenede Stater
    • New Jersey
      • Novartis US, New Jersey, Forenede Stater
        • Novartis US
  • Holland
      • Novartis Netherlands, Holland
        • Novartis Netherlands
  • Indien
      • Worli, Mumbai, Indien, 400018
        • Novartis Healthcare Private Limited
  • Israel
      • Petach Tikva, Israel, IL-49250
        • Novartis Pharma
  • Italien
      • Novartis Italy, Italien
        • Novartis Italy
  • Kalkun
      • Istanbul, Kalkun, TR-34353
        • Novartis Turkey
  • Korea, Republikken
      • Seoul, Korea, Republikken, 100-803
        • Novartis Korea Ltd.
  • Norge
      • Novartis Norway, Norge
        • Novartis Norway
  • Polen
      • Warszawa, Polen, PL-00-710-
        • Novartis Poland Sp. z o.o.
  • Slovakiet
      • Bratislava, Slovakiet, SK-821 09
        • Novartis Slovakia
  • Spanien
      • Novartis Spain, Spanien
        • Novartis Spain
  • Sverige
      • Novartis Sweden, Sverige
        • Novartis Sweden
  • Tjekkiet
    • Praha 3
      • Praha, Praha 3, Tjekkiet, CZ-130 00
        • Novartis Czech Republic
  • Tyskland
      • Novartis Germany, Tyskland
        • Novartis Germany
  • Ungarn
      • Budapest, Ungarn, H-1537
        • Novartis Hungary
  • Venezuela
      • Caracas, Venezuela, 1062
        • Novartis de Venezuela, S.A.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Aliskiren
Aliskiren was available in 75 mg tablet, 150 mg tablet
Andre navne:
  • Tekturna®
Placebo komparator: placebo
Core study: placebo for 36 weeks once daily in the morning
Medicin: placebo
Placebo tablets matching aliskiren for 36 weeks once daily in the morning for core period only.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Core Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) as Measured by Echocardiography at End of Study.
Tidsramme: Baseline and final visit (after 26 to 36 weeks of treatment)
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.
Baseline and final visit (after 26 to 36 weeks of treatment)
Extension Study: Percentage of Participants With Deaths, Serious Adverse Events (SAEs), Discontinuation for Adverse Events (AEs) and Discontinuations for Abnormal Lab Values
Tidsramme: Extension study (24 weeks)
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.
Extension study (24 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Core Study: Time to First Occurrence for the Composite Endpoints of Echocardiogram and Adjudicated Outcomes
Tidsramme: 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).
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).
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).
Core Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV)
Tidsramme: Baseline and final visit (after 26 to 36 weeks of treatment)
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.
Baseline and final visit (after 26 to 36 weeks of treatment)
Core Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Tidsramme: Baseline and final visit (after 26 to 36 weeks of treatment )
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.
Baseline and final visit (after 26 to 36 weeks of treatment )
Core Study: Change From Baseline to End of Study in Infarction Segment Length (ISL) as Measured by Echocardiography
Tidsramme: Baseline and final visit (after 26 to 36 weeks of treatment)
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.
Baseline and final visit (after 26 to 36 weeks of treatment)
Core Study: Change From Baseline to End of Study in Wall Motion Score (WMS) as Measured by Echocardiography
Tidsramme: Baseline and final visit (after 26 to 36 weeks of treatment)
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.
Baseline and final visit (after 26 to 36 weeks of treatment)
Extension Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 12
Tidsramme: Baseline(extension study), Month 12 (extension study)
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.
Baseline(extension study), Month 12 (extension study)
Extension Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 12
Tidsramme: Baseline (extension study), Month 12 (extension study)
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.
Baseline (extension study), Month 12 (extension study)
Extension Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 12
Tidsramme: Baseline(extension study), Month 12 (extension study)
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.
Baseline(extension study), Month 12 (extension study)
Extension Study: Percentage of Participants With Orthostatic Blood Pressure Change
Tidsramme: Baseline (Day 0 Extension study), Week 2, Months 1, 3, 6, 9,16, 20, 24
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.
Baseline (Day 0 Extension study), Week 2, Months 1, 3, 6, 9,16, 20, 24
Extension Study: Percentage of Participants With Specified Criteria in Selected Labs by Laboratory Parameter
Tidsramme: 24 Months

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis

Efterforskere

  • Studiestol: Novartis US, Novartis

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2006

Primær færdiggørelse (Faktiske)

1. september 2009

Studieafslutning (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først indsendt

19. december 2006

Først indsendt, der opfyldte QC-kriterier

20. december 2006

Først opslået (Skøn)

21. december 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. juli 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juli 2012

Sidst verificeret

1. juli 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CSPP100A2340

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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