Ad5FGF-4 In Patients With Refractory Angina Due to Myocardial Ischemia (AFFIRM)
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
Researchers at Angiogetics Inc. seek participants for clinical trial testing of a one-time treatment to transfer a therapeutic gene into the heart that is designed to reduce angina attacks, reduce nitroglycerin usage, and improve quality of life. This investigatory treatment involves a single intracoronary (into the heart) injection of a harmless virus that delivers a human fibroblast growth factor that promotes growth of new blood vessels to feed the heart muscles.
The investigatory treatment would be administered one time using a standard balloon catheter. Half of the participants would receive a placebo.
- Be 55 to 75 years of age
- Meet study criteria regarding the severity of their coronary artery disease
- Have at least 5 angina episodes per week on average
- Not have a history of myocardial infarction (heart attack) in the 3 months before screening
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility and safety of the patient to participate.
- Balloon catheter and intracoronary injection of the investigatory drug (or placebo) will be given.
- Follow up at baseline, then at 6 and 12 months, with long term follow up through 5 years.
LOCATIONS AND CONTACTS:
Your doctor may contact study contacts to determine locations and eligibility.
Contact: Lois A Chandler, PhD | 858-386-8416 | [email protected]
Contact: Christopher Reinhard | 858-436-1000 | [email protected]
Huapont Life Sciences
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