Back to resultsSafety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aliskiren
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring myocardial infarction, aliskiren, heart failure, Post acute myocardial infarction with systolic dysfunction
Eligibility 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
Sites / Locations
- Novartis US
- Novartis Argentina
- Novartis Belgium
- Novartis Canada
- Novartis de Colombia S.A.
- Novartis Czech Republic
- Novartis Denmark
- Novartis Germany
- Novartis Hungary
- Novartis Healthcare Private Limited
- Novartis Pharma
- Novartis Italy
- Novartis Korea Ltd.
- Novartis Netherlands
- Novartis Norway
- Novartis Poland Sp. z o.o.
- Novartis Russia
- Novartis Slovakia
- Novartis Spain
- Novartis Sweden
- Novartis Turkey
- Novartis UK
- Novartis de Venezuela, S.A.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aliskiren
placebo
Arm 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.
Core study: placebo for 36 weeks once daily in the morning
Outcomes
Primary Outcome Measures
Core Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) as Measured by Echocardiography at End of Study.
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.
Extension Study: Percentage of Participants With Deaths, Serious Adverse Events (SAEs), Discontinuation for Adverse Events (AEs) and Discontinuations for Abnormal Lab Values
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.
Secondary Outcome Measures
Core Study: Time to First Occurrence for the Composite Endpoints of Echocardiogram and Adjudicated Outcomes
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).
Core Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV)
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.
Core Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
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.
Core Study: Change From Baseline to End of Study in Infarction Segment Length (ISL) as Measured by Echocardiography
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.
Core Study: Change From Baseline to End of Study in Wall Motion Score (WMS) as Measured by Echocardiography
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.
Extension Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 12
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.
Extension Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 12
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.
Extension Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 12
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.
Extension Study: Percentage of Participants With Orthostatic Blood Pressure Change
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.
Extension Study: Percentage of Participants With Specified Criteria in Selected Labs by Laboratory Parameter
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00414609
Brief Title
Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
myocardial infarction, aliskiren, heart failure, Post acute myocardial infarction with systolic dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
820 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aliskiren
Arm Type
Experimental
Arm 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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Core study: placebo for 36 weeks once daily in the morning
Intervention Type
Drug
Intervention Name(s)
Aliskiren
Other Intervention Name(s)
Tekturna®
Intervention Description
Aliskiren was available in 75 mg tablet, 150 mg tablet
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo tablets matching aliskiren for 36 weeks once daily in the morning for core period only.
Primary Outcome Measure Information:
Title
Core Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) as Measured by Echocardiography at End of Study.
Description
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.
Time Frame
Baseline and final visit (after 26 to 36 weeks of treatment)
Title
Extension Study: Percentage of Participants With Deaths, Serious Adverse Events (SAEs), Discontinuation for Adverse Events (AEs) and Discontinuations for Abnormal Lab Values
Description
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.
Time Frame
Extension study (24 weeks)
Secondary Outcome Measure Information:
Title
Core Study: Time to First Occurrence for the Composite Endpoints of Echocardiogram and Adjudicated Outcomes
Description
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).
Time Frame
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).
Title
Core Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV)
Description
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.
Time Frame
Baseline and final visit (after 26 to 36 weeks of treatment)
Title
Core Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Description
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.
Time Frame
Baseline and final visit (after 26 to 36 weeks of treatment )
Title
Core Study: Change From Baseline to End of Study in Infarction Segment Length (ISL) as Measured by Echocardiography
Description
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.
Time Frame
Baseline and final visit (after 26 to 36 weeks of treatment)
Title
Core Study: Change From Baseline to End of Study in Wall Motion Score (WMS) as Measured by Echocardiography
Description
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.
Time Frame
Baseline and final visit (after 26 to 36 weeks of treatment)
Title
Extension Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 12
Description
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.
Time Frame
Baseline(extension study), Month 12 (extension study)
Title
Extension Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 12
Description
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.
Time Frame
Baseline (extension study), Month 12 (extension study)
Title
Extension Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 12
Description
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.
Time Frame
Baseline(extension study), Month 12 (extension study)
Title
Extension Study: Percentage of Participants With Orthostatic Blood Pressure Change
Description
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.
Time Frame
Baseline (Day 0 Extension study), Week 2, Months 1, 3, 6, 9,16, 20, 24
Title
Extension Study: Percentage of Participants With Specified Criteria in Selected Labs by Laboratory Parameter
Description
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)
Time Frame
24 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis US
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis US
City
Novartis US
State/Province
New Jersey
Country
United States
Facility Name
Novartis Argentina
City
Novartis Argentina
Country
Argentina
Facility Name
Novartis Belgium
City
Novartis Belgium
Country
Belgium
Facility Name
Novartis Canada
City
Novartis Canada
Country
Canada
Facility Name
Novartis de Colombia S.A.
City
Bogota
Country
Colombia
Facility Name
Novartis Czech Republic
City
Praha
State/Province
Praha 3
ZIP/Postal Code
CZ-130 00
Country
Czech Republic
Facility Name
Novartis Denmark
City
Novartis Denmark
Country
Denmark
Facility Name
Novartis Germany
City
Novartis Germany
Country
Germany
Facility Name
Novartis Hungary
City
Budapest
ZIP/Postal Code
H-1537
Country
Hungary
Facility Name
Novartis Healthcare Private Limited
City
Worli, Mumbai
ZIP/Postal Code
400018
Country
India
Facility Name
Novartis Pharma
City
Petach Tikva
ZIP/Postal Code
IL-49250
Country
Israel
Facility Name
Novartis Italy
City
Novartis Italy
Country
Italy
Facility Name
Novartis Korea Ltd.
City
Seoul
ZIP/Postal Code
100-803
Country
Korea, Republic of
Facility Name
Novartis Netherlands
City
Novartis Netherlands
Country
Netherlands
Facility Name
Novartis Norway
City
Novartis Norway
Country
Norway
Facility Name
Novartis Poland Sp. z o.o.
City
Warszawa
ZIP/Postal Code
PL-00-710-
Country
Poland
Facility Name
Novartis Russia
City
Novartis Russia
Country
Russian Federation
Facility Name
Novartis Slovakia
City
Bratislava
ZIP/Postal Code
SK-821 09
Country
Slovakia
Facility Name
Novartis Spain
City
Novartis Spain
Country
Spain
Facility Name
Novartis Sweden
City
Novartis Sweden
Country
Sweden
Facility Name
Novartis Turkey
City
Istanbul
ZIP/Postal Code
TR-34353
Country
Turkey
Facility Name
Novartis UK
City
Novartis
Country
United Kingdom
Facility Name
Novartis de Venezuela, S.A.
City
Caracas
ZIP/Postal Code
1062
Country
Venezuela
12. IPD Sharing Statement
Citations:
PubMed Identifier
21317148
Citation
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.
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Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)
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