NCT01550614

Efficacy and Safety of Ad5FGF-4 for Myocardial Ischemia in Patients With Stable Angina Due to Coronary Artery Disease

A Randomized, Controlled, Parallel Group, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Ad5FGF-4 Using SPECT Myocardial Perfusion Imaging in Patients With Stable Angina Pectoris

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Cardium Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4, delivered during induced transient ischemia, is effective in improving myocardial perfusion, angina functional class, patient symptoms, and quality of life. Short-term (8 weeks) and long-term (12 month) safety of Ad5FGF-4 will also be evaluated. The primary endpoint is change in adenosine triphosphate (ATP) stress SPECT reperfusion defect size.

Conditions

• Angina, Stable

Interventions

Type	Name	Description
GENETIC	Alferminogene tadenovec	One-time intracoronary infusion of Ad5FGF-4 (6x10e9 viral particles in buffer)

Timeline

• Start date: 2012-03-01
• Primary completion: 2016-05-01
• First posted: 2012-03-12
• Last updated: 2016-09-29

Locations

1 site across 1 country: Russia