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Ad5FGF-4 In Patients With Refractory Angina Due to Myocardial Ischemia — AFFIRM  

Angina, Stable Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Phase 3 Study to Evaluate the Safety and Efficacy of Ad5FGF-4 in Patients With Refractory Angina Due to Myocardial Ischemia

Clinical Trial Summary

The purpose of this study is to determine whether a single intracoronary infusion of an adenovirus serotype 5 virus expressing the gene for human fibroblast growth factor-4 (Ad5FGF-4) is effective in improving angina-limited exercise duration, angina functional class, frequency of angina attacks, frequency of nitroglycerin usage, and quality of life. Half of the study participants will receive Ad5FGF-4, and half will receive placebo. The primary endpoint is the change from baseline to Month 6 in Exercise Tolerance Test (ETT) duration. Long-term safety of Ad5FGF-4 will also be assessed.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02928094
Study type Interventional
Source Angionetics Inc.
Contact Christopher Reinhard
Phone 858-414-1477
Email creinhard@angionetics.com
Status Not yet recruiting
Phase Phase 3
Start date January 1, 2023
Completion date December 31, 2024
View Details
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