Safety and Efficacy of Intracoronary Ad5FGF-4 in Patients With Stable Angina

A Multinational Multicenter, Randomized , Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Patients With Stable Angina

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00185263

Acronym

AGENT-4

Enrollment

116

Registered

2005-09-16

Start date

2002-03-31

Completion date

2008-11-30

Last updated

2008-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable Angina

Keywords

angina, FGF-4, angiogenesis, adenovector, growth factor, myocardial ischemia, revascularization

Brief summary

The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4 is effective in improving exercise capacity measured by exercise treadmill testing, angina functional class, patient symptoms, quality of life, and cardiovascular outcomes. To doses are to be studied, 2.87x10(8) and 2.87x10(9) viral particles, to evaluate the dose-response of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.

Interventions

GENETICAdF5FGF-4 vs. Placebo

Intracoronary infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

Inclusion criteria

* CCS class II - IV, technically unsuitable for revascularization by CABG or PTCA able to exercise between 3 and 10 minutes on treadmill

Exclusion criteria

* Unstable angina, CCS class 1 angina optimal candidates for revascularization

Design outcomes

Primary

Measure	Time frame
Treadmill exercise duration	Week 12

Secondary

Measure	Time frame
Time to coronary events	1 Year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026