Journal Article

The AGENT clinical trials programme

C.L Grines

in European Heart Journal Supplements

Published on behalf of European Society of Cardiology

Volume 6, issue suppl_E, pages E18-E23
Published in print September 2004 | ISSN: 1520-765X
Published online September 2004 | e-ISSN: 1554-2815 | DOI: http://dx.doi.org/10.1016/j.ehjsup.2004.06.002
The AGENT clinical trials programme

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AGENT and AGENT 2 are the first randomized, double-blind, placebo-controlled trials studying the benefits of stimulating coronary angiogenesis with gene therapy. To promote collateral circulation, Ad5FGF-4 was infused into coronary arteries of patients with chronic stable angina.

AGENT evaluated doses of Ad5FGF-4 from 3.3×108 to 3.3×1010 vp in 60 patients who tolerated the therapy well. Exercise time on a treadmill (ETT) improved in patients with baseline ETTs ⩽10 min, but not in pooled data from all doses. Additionally, 50% of patients given 1×1010 vp had increased ETT, versus 16% in the placebo group ([math] and 16, respectively, [math]). Doses of 1010 and 109 vp were chosen for further study.

AGENT 2 determined whether Ad5FGF-4 improved myocardial perfusion compared with placebo. A significant decrease in ischaemic defect size was observed in patients treated with Ad5FGF-4 compared with baseline ([math], 21% relative decrease, [math]) that was not found in placebo group ([math], [math]). Again, Ad5FGF-4 was well tolerated.

AGENT 3 and 4 trials were planned to determine the efficacy and safety of Ad5FGF-4 in selected doses in larger populations. An interim review of the data from AGENT 3 indicated no safety concerns. However, differences in ETT were unlikely to reach significance. Therefore, further recruitment in the trials was stopped.

Keywords: Myocardial ischaemia; Stable angina; Angiogenesis; Fibroblast growth factor; Adenovirus; Clinical trials

Journal Article.  3127 words.  Illustrated.

Subjects: Cardiovascular Medicine

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