Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE) - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00414609

Purpose

This study will assess 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).

Condition	Intervention	Phase
Myocardial Infarction	Drug: Aliskiren Drug: placebo	Phase III

MedlinePlus related topics: Heart Attack Heart Failure

Drug Information available for: Aliskiren

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 36-Week 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

Further study details as provided by Novartis:

Primary Outcome Measures:

Change in left ventricular end systolic volume (LVESD) as measured by echocardiography [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cardiovascular-related deaths, hospitalization for heart failure, recurrent myocardial infarction, stroke, and resuscitated sudden deaths [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Change in left ventricular end diastolic volume [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Change in left ventricular ejection fraction [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Overall safety and tolerability [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	December 2006
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Aliskiren	Drug: Aliskiren Aliskiren
2: Placebo Comparator placebo	Drug: placebo placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

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 MSSBP ≥ 180 mmHg and/or 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

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414609

Contacts

Contact: Novartis US	862-778-8300
Contact: Novartis Basel	41-61-324-1111

Show 25 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis US

Novartis

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CSPP100A2340
Study First Received:	December 19, 2006
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00414609
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Belgium: Ministry of Social Affairs, Public Health and the Environment; Brazil: National Health Surveillance Agency; Canada: Canadian Institutes of Health Research; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; India: Ministry of Health; Israel: Israeli Health Ministry Pharmaceutical Administration; Italy: The Italian Medicines Agency; South Korea: Korea Food and Drug Administration (KFDA); Netherlands: Medicines Evaluation Board (MEB); Norway: Norwegian Medicines Agency; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Pharmacological Committee, Ministry of Health; Slovakia: State Institute for Drug Control; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Turkey: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Venezuela: Ministry of Health and Social Development

Keywords provided by Novartis:

myocardial infarction, aliskiren, heart failure
Post acute myocardial infarction with systolic dysfunction

Study placed in the following topic categories:

Necrosis
Heart Failure
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009