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

Phase 3

Completed

• Conditions: Health Condition 1: null- Myocardial Infarction

• Registration Number: CTRI/2009/091/000197
• Lead Sponsor: ovartis Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 800

Inclusion Criteria

1) Male or female patients 18 years and older.

2) Patients within 7-42 days of an acute myocardial infarction associated with left ventricular systolic dysfunction.

3) Documented left ventricular systolic dysfunction associated with the qualifying acute myocardial.

4) 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:

oA Beta-blocker

oAn Anti-platelet agent

oA Statin

oAn evidence-based dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) but not both.

5) Qualifying Echocardiogram at Visit 1

Exclusion Criteria

1) Patients requiring both Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin Receptor Blocker (ARB) combination therapy at V1 or any time during the study.
2) Severe refractory hypertension defined as MSSBP ≥ 180 mmHg and/or MSDBP ≥ 110 mmHg) at Visit 2.
3) Cardiogenic shock or systolic BP < 100 mmHg or diastolic < 60 mmHg within the 24 hours prior to Visits 1 or 2
4) Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2 using the MDRD formula at Visit 1.
5) Stroke or transient ischemic event (TIA) within 6 months of Study Visit 1

Study & Design

• Study Type: Interventional
• Study Design: Not specified