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IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction

NCT01226563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2023-02-27

No results posted yet for this study

Summary

The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for the prevention of ventricular remodeling and congestive heart failure when administered to subjects who had successful percutaneous coronary intervention with stent placement after ST segment elevation MI (STEMI).

Conditions

  • Acute Myocardial Infarction
  • Congestive Heart Failure
  • ST-Elevation Myocardial Infarction

Interventions

DEVICE

IK-5001

4 mL (+/- 0.2 mL) administered through intracoronary slow bolus injection over 15 to 30 seconds at least 2 days after PCI but within 5 days of onset of symptoms.

DEVICE

Saline Solution

4 mL (+/- 0.2 mL) slow bolus, intracoronary injection of saline solution will be administered over 15 to 30 seconds at least 2 days after percutaneous coronary intervention (PCI) but within 5 days of onset of symptoms.

Sponsors & Collaborators

  • Bellerophon BCM LLC

    lead INDUSTRY

Principal Investigators

  • Ashika Ahmed, MD · Bellerophon Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-08-31
Completion
2015-12-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Israel
  • Poland
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01226563 on ClinicalTrials.gov