Botulinum toxin type A (AGN-151607) for the prevention of post operative atrial fibrillation in patients undergoing open-chest cardiac surgery
- Conditions
- Post-operative atrial fibrillation (POAF)MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-004399-68-ES
- Lead Sponsor
- Allergan Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 330
- 55 to 90 years of age, inclusive, at the time of signing the informed consent;
- scheduled to undergo open-chest cardiac surgery (includes: coronary artery bypass graft [CABG] and/or valve repair/replacement);
- in sinus rhythm for the last 48 hours prior to surgery (prior history of paroxysmal AF is acceptable);
- willing to wear an electrocardiogram (ECG) patch for 30 days post-surgery and for 7 days after each study visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
- any medical condition that may put the participant at increased risk with exposure to botulinum toxin type A, including diagnosed muscular dystrophy (eg, Duchenne’s muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease which might interfere with neuromuscular function;
- participants with presence or history of any of the following within 3 months prior to the Day 1 visit that may indicate a vulnerable respiratory state per the investigator’s clinical judgment: aspiration pneumonia, lower respiratory tract infections, uncontrolled asthma, severe chronic obstructive pulmonary disease or otherwise compromised respiratory function;
- permanent/persistent AF;
- has a known allergy or sensitivity to any botulinum toxin type A preparation;
- has a known allergy or sensitivity to medical adhesive (eg, ECG patch adhesive; hydrogel based adhesive); severe (> 55mm) atrial enlargement; left ventricular ejection fraction (LVEF) < 25%;
- presence or history of symptomatic atrioventricular block > 1st degree within the last 30 days;
- prior or concomitant therapy with Class I or III antiarrhythmic drugs unless proper washout was documented;
- botulinum toxin type A (of any serotype) use within 6 months of randomization;
- has been immunized for any botulinum toxin type A serotype as determined by participant medical history;
- preoperative need for inotropes/vasopressors or intra-aortic balloon pump;
- prior cardiac surgery;
- history of ablation for AF;
- planned ablation procedure for AF at the time of surgery;
- emergency surgery;
- impaired prognosis defined as EuroSCORE II greater than 7% perioperative mortality.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy of AGN-151607 with placebo to prevent post-operative atrial fibrillation (POAF) in participants who are undergoing open chest cardiac surgery;Secondary Objective: - To compare the efficacy of AGN-151607 with placebo to reduce AF burden in participants who are undergoing open-chest cardiac surgery <br> - To compare the efficacy of AGN-151607 with placebo to prevent POAF using alternative definitions for AF in participants who are undergoing open-chest cardiac surgery<br> - To compare the safety of AGN-151607 with placebo in participants undergoing open-chest cardiac surgery;Primary end point(s): Percentage of participants with at least 1 continuous atrial fibrillation (AF) episode = 30 seconds during the first 30 days post surgery;Timepoint(s) of evaluation of this end point: within the first 30 days post surgery
- Secondary Outcome Measures
Name Time Method