AGN 151607 Injections to Prevent Post-Op AF
Research type
Research Study
Full title
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN 151607) Injections into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery
IRAS ID
253596
Contact name
Malcolm Dalrymple-Hay
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2017-004399-68
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 2 days
Research summary
This is a study of drug AGN-151607, (a botulinum toxin type A) as a possible treatment to prevent post-operative atrial fibrillation (POAF) in participants undergoing an open-chest heart procedure. The study is sponsored by Allergan (a pharmaceutical company).
Post-operative atrial fibrillation (POAF) can occur in up to 60% of patients undergoing coronary artery by-pass and/or cardiac valve surgical procedures. Atrial fibrillation is when the heartbeat becomes irregular. Suffering from atrial fibrillation after surgery can be associated with longer hospital stays and a higher risk of stroke.
The main purpose of this study is to learn how well a one-time treatment with study drug works in preventing post-operative atrial fibrillation and how safe the study drug is compared to placebo. A placebo is an inactive material that looks like the study drug but does not contain any active study drug. Researchers use a placebo to see if the study drug works better or is safer than taking nothing. Participants will have a 33.3% (1 in 3) chance of receiving 125U of AGN-151607, 250U of AGN-151607, or placebo and will not know which treatment they are receiving. U is a measurement for BoNT dosage.
The study drug or placebo will be injected into the fat pads that surround the heart; these injections will take place during planned open-chest heart procedure. These fat pads become accessible during an open-chest heart procedure.
This study will take place in approximately 20 to 30 sites (e.g. hospitals) across North America and Europe.
About 330 people are planned to participate in this study. Everybody participating in this study will already be scheduled for an open-chest heart procedure.
Participants will be in this study for approximately a year, and will come to the study centre at least 8 times over this period.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0345
Date of REC Opinion
1 Feb 2019
REC opinion
Further Information Favourable Opinion