NL-OMON55701撤回2 期
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 - Allergan 1925-201-008
Allergan Ltd.0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 30
研究概览
简要总结
Trial never started
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1.01- Participants must be 55 to 90 years of age, inclusive, at the time of
- •signing the informed consent.
- •2.01- Participants who are scheduled to undergo open-chest cardiac surgery.
- •Includes: coronary artery bypass graft (CABG) and/or valve repair/replacement.
- •3.01- Male or female
- •4.01- Male participants willing to minimize the risk of inducing pregnancy up
- •to Day 60.
- •A male participant must agree to use contraception as detailed in Appendix 7,
- •Section 10.7 of this protocol until Day 60 and refrain from donating sperm
- •during this period.
- •4.02- Female participants willing to minimize the risk of inducing pregnancy up
- •to Day 60.
- •A female participant is eligible to participate if she is not pregnant (has a
- •negative urine pregnancy result prior to randomization) not breastfeeding, and
- •at least 1 of the following conditions applies:
- •a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 7,
- •Section 10.7
- •b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 7,
- •Section 10.7 of this protocol until after Day 60.
- •5.01- Capable of giving signed informed consent as described in Appendix 1,
- •Section 10.1, which includes compliance with the requirements and restrictions
- •listed in the informed consent form (ICF) and in this protocol.
- •5.02- Written informed consent from the participant has been obtained prior to
- •any study related procedures.
- •5.03- Written documentation has been obtained in accordance with the relevant
- •country and local privacy requirements, where applicable (eg, Written
- •Authorization for Use and Release of Health and Research Study Information [US
- •sites] and written Data Protection consent (European Union [EU] sites).
- •6.01- In sinus rhythm for the last 48 hours prior to surgery (prior history of
- •paroxysmal atrial fibrillation (AF) is acceptable).
- •6.02- Willing to wear an electrocardiogram (ECG) patch for 30 days post-surgery
- •and for 7 days after each study visit
- •6.03- Able, as assessed by the investigator, and willing to follow study
- •instructions and likely to complete required study visit.
排除标准
- •1.01- Any uncontrolled clinically significant medical condition other than the
- •one under study that, in the investigator*s opinion, would put the participant
- •at an unacceptable risk with exposure to botulinum toxin type A.
- •1.02- 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.
- •1.03- 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.
- •1.04- Permanent/persistent atrial fibrillation (AF)
- •1.05- Has a known allergy or sensitivity to any botulinum toxin type A
- •preparation.
- •1.06- Has a known allergy or sensitivity to medical adhesive (eg, ECG patch
- •adhesive; hydrogel-based adhesive).
- •1.07- Severe (> 55mm) atrial enlargement
- •1.08- Left ventricular ejection fraction (LVEF) < 25%
- •1.09- Presence or history of symptomatic atrioventricular block > 1st degree
- •within the last 30 days
- •2.01- Class I or III antiarrhythmic drugs unless proper washout was documented
- •(Section 6.5.1)
- •2.02- Botulinum toxin type A (of any serotype) use within 6 months of
- •randomization
- •2.03- Has been immunized for any botulinum toxin type A serotype as determined
- •by participant medical history
- •2.04- Preoperative need for inotropes/vasopressors or intra-aortic balloon pump
- •2.05- Prior cardiac surgery
- •2.06- History of ablation for AF
- •2.07- Planned ablation procedure for AF at the time of surgery
- •2.08- Emergency surgery
- •3.01- Current enrollment in an investigational drug or device study or
- •participation in such a study within 30 days of entry into this study
- •4.01- Participants have diagnostic assessments which in the opinion of the
- •investigator prevent participation in the study.
- •4.02- Impaired prognosis defined as EuroSCORE II greater than 7% perioperative
- •5.01- Females who are pregnant, nursing, or planning a pregnancy during the
- •5.02- The participant has a condition or is in a situation which, in the
- •investigator*s opinion, may put the participant at significant risk, may
- •confound the study results, or may interfere significantly with the
- •participant*s participation in the study.
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