A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 2,500
- 主要终点
- Time to first ISTH major Bleeding events
研究概览
简要总结
This OLE part is an optional, single arm, multicenter, open-label extension (OLE) added to the core part to assess the long-term safety, tolerability, the incidence of ischemic stroke or SE and bleeding events of abelacimab in eligible patients who completed the double-blinded core part of CMAA868A2302 (ANT-010/NCT05712200)
详细描述
Patients who provide consent, will need to complete the end of treatment visit (EoT) assessments of the Core Part of CMAA868A2302 (ANT-010/NCT05712200) prior to receiving first dose in the OLE. Day 1 visit or dosing should occur on same day as EoT visit to avoid treatment interruption.
Participation in OLE will end if a patient permanently discontinues study treatment, or the study is completed or terminated by the Sponsor.
All patients will need to complete End of Study in Extension visit in person followed by a phone call visit 30 days after End of Extension visit. Any updates in AE or concomitant medications will be reported by a phone call/video call visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are able to provide written informed consent to enter the extension part.
- •Patients must be on study treatment at the time of EoT visit in the core part.
排除标准
- •Patients meeting any exclusion criteria in the core part.
- •Patients who have a history or evidence of any clinically significant disorder, condition, or disease that in the investigator's opinion or Sponsor physician (if consulted), would put the participant at risk or interfere with the study participation
- •History of hypersensitivity to the study drug or its excipients, to drugs of similar chemical classes
- •Any medical or psychiatric condition which in the judgment of the Investigator either requires urgent medical intervention/hospitalization or may preclude patients from complying with study requirements for the duration of the study.
- •Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Abelacimab (MAA868)
abelacimab 150 mg subcutaneous (SC)
干预措施: Abelacimab (Biological)
结局指标
主要结局
Time to first ISTH major Bleeding events
时间窗: Up to 3 years
Time to first International Society on Thrombosis and Haemostasis (ISTH) major bleeding events
Time to first BARC type 3c/5 bleeding
时间窗: Up to 3 years
Time to first Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding
Number of participants with ISTH major or CRNM bleeding
时间窗: Up to 3 years
Number of participants with International Society on Thrombosis and Haemostasis (ISTH) major or clinically relevant non-major (CRNM) bleeding
Number of participants with bleeding
时间窗: Up to 3 years
All suspected bleeding events either reported by the patient or observed by the Investigator
Number of participants with TEAEs and TESAEs
时间窗: Up to 3 years
Number of participants with treatment emergent AEs (TEAEs) and treatment emergent SAEs (TESAEs)
Number of participants with treatment discontinuations due to TEAEs
时间窗: Up to 3 years
Number of participants with treatment discontinuations due to treatment emergent AEs (TEAEs)
Number of participants with device related AEs, SAEs, and device deficiencies
时间窗: Up to 3 years
次要结局
- Time to first event of ischemic stroke or SE(Up to 3 years)