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Myocardial Ischemia - Healing Genes
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Myocardial Ischemia

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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


Phase 3

DESCRIPTION:
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.


PATIENT MUST:

  • 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:

  1. Prescreening tests to confirm eligibility and safety of the patient to participate.
  2. Balloon catheter and intracoronary injection of the investigatory drug (or placebo) will be given.
  3. 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]
 
SPONSOR INFORMATION:
Angionetics Inc.
Huapont Life Sciences
Or go online:
https://clinicaltrials.gov/ct2/show/NCT02928094

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