Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery (NOVA)
Summary
This was a multi-center, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to evaluate the efficacy and safety of botulinum toxin type A (AGN-151607) injections into the epicardial fat pads, foci of ganglionic plexi, to prevent Post-Operative Atrial Fibrillation (POAF) in patients undergoing open-chest cardiac surgery.
Timeline
- Start
- 2019-03-01
- Primary completion
- 2022-03-24
- Completion
- 2023-03-06
Outcome
Missed primary endpoint
registry analysis (superiority test); AGN-151607 (125 U); p = 0.1612; Risk Ratio (RR) 0.80 (95% CI 0.58 to 1.10); Cochran-Mantel-Haenszel NCT03779841 ↗
registry analysis (superiority test); AGN-151607 (250 U); p = 0.7789; Risk Ratio (RR) 1.04 (95% CI 0.79 to 1.37); Cochran-Mantel-Haenszel NCT03779841 ↗
paper There were no significant differences in the rate of POAF with either dose compared with placebo PMID 38661602 ↗
Publications
- Piccini JP, Ahlsson A, Dorian P, Gillinov AM, Kowey PR, Mack MJ, Milano CA, Noiseux N, Perrault LP, Ryan W, Steinberg JS, Voisine P, Waldron NH, Gleason KJ, Titanji W, Leaback RD, O'Sullivan A, Ferguson WG, Benussi S; NOVA-AF Investigators. Efficacy and Safety of Botulinum Toxin Type A for the Prevention of Postoperative Atrial Fibrillation. JACC Clin Electrophysiol. 2024 May;10(5):930-940. doi: 10.1016/j.jacep.2024.01.020. Epub 2024 Apr 24.
- Piccini JP, Ahlsson A, Dorian P, Gillinov MA, Kowey PR, Mack MJ, Milano CA, Perrault LP, Steinberg JS, Waldron NH, Adams LM, Bharucha DB, Brin MF, Ferguson WG, Benussi S. Design and Rationale of a Phase 2 Study of NeurOtoxin (Botulinum Toxin Type A) for the PreVention of Post-Operative Atrial Fibrillation - The NOVA Study. Am Heart J. 2022 Mar;245:51-59. doi: 10.1016/j.ahj.2021.10.114. Epub 2021 Oct 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 125 iu | Other |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 250 iu | Other |