A 36 week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricular remodeling in high risk post-acute myocardial infarct patients when added to optimized standard therapy

A 36 week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricular remodeling in high risk post-acute myocardial infarct patients when added to optimized standard therapy - ASPIRE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30339

Enrollment

Registered

2006-10-10

Start date

2007-02-05

Completion date

Unknown

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart attack myocardial infarct

Interventions

There are two treatment groups: 1) Aliskiren 75 mg, force-titrated via 150 mg Aliskiren to 300 mg Aliskiren (in a period of 2 weeks) 2) Placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: See protocol for complete criteria (page 17);*Male and female patients 18 years and older. *Patients within 7-42 days of an acute myocardial infarction. *Documented left ventricular systolic dysfunction associated with the qualifying acute myocardial infarction obtained as a clinical study at least 5 days after the qualifying MI but prior to Visit 1. *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.

Exclusion criteria

Exclusion criteria: See protocol for complete criteria (page 18) *Patients requiring both ACE and ARB combination therapy at Visit 1. *Severe refractory hypertension defined as MSSBP *180 mmHg and/or MSDBP * 110 mmHg at randomization (visit 2). *Secondary forms of cardiomyopathy such as restrictive cardiomyopathy or infective cardiomyopathy *Stroke or transchemient ischemic event (TIA) within 6 months of Study visit 1. *Serum potassium *5.1 mEq/L, or dehydration at study visit 1 *Estimated Glomerular filtration rate

Design outcomes

Primary

Measure	Time frame
Echocardiography: The primary efficacy endpoint will be change in left ventricular end systolic volume (LVESV) from baseline to end of study. Additional echocardiographic measures will serve as secondary endpoints, including left ventricular end-diastolic volume (LVEDV) and left ventricular ejection fraction (LVEF).	—

Secondary

Measure	Time frame
Cardiac MRI (in a subset of patients- not in the Netherlands): RV and LV volumes, LVEF, and myocardial infarct related scarring as determined by contrast enhanced MRI. Composite clinical endpoints: a composite outcome of CV death, hospitalization for heart failure, or a reduction in left ventricular ejection fraction greater than 6 units (absolute percentage points) *a composite outcome of CV death, hospitalization for heart failure, recurrent myocardial infarction, stroke or resuscitated sudden death.	—

Measure

Time frame

Cardiac MRI (in a subset of patients- not in the Netherlands): *RV and LV volumes, LVEF, and myocardial infarct related scarring as determined by contrast enhanced MRI. Composite clinical endpoints: *a composite outcome of CV death, hospitalization for heart failure, or a reduction in left ventricular ejection fraction greater than 6 units (absolute percentage points) *a composite outcome of CV death, hospitalization for heart failure, recurrent myocardial infarction, stroke or resuscitated sudden death.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)