CTRI/2024/02/062973招募中3 期
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).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,900
- 试验地点
- 39
- 主要终点
- Efficacy: Time to first event of ischemic stroke or systemic embolism (SE)
研究概览
简要总结
A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 65.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient is able to understand and willing to provide written informed consent to participate in the trial Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording) Age 65-74 and a CHA2DS2VASc ≥5 OR age ≥75 and a CHA2DS2VASc ≥4 Judged by the responsible physician or by their own decision to be unsuitable for oral anticoagulation At least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (NSAID) use, frailty or multiple falls.
排除标准
- •AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use) Patients who received warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban within 60 days prior to randomization Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment Any stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomization Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study.
结局指标
主要结局
Efficacy: Time to first event of ischemic stroke or systemic embolism (SE)
时间窗: Efficacy: Up to 30 months | Safety: Up to 30 months
Safety: Time to first occurrence of Bleeding Academic Research Consortium (BARC) type 3c slash 5 bleeding
时间窗: Efficacy: Up to 30 months | Safety: Up to 30 months
次要结局
- Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), or acute limb ischemia(Up to 30 months)
- Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), or Bleeding Academic Research Consortium (BARC) type 3c slash 5 bleeding event(Up to 30 months)
- Efficacy: Cardiovascular (CV) mortality(Up to 30 months)
- Efficacy: All-cause mortality(Up to 30 months)
- Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), acute limb ischemia, or International Society on Thrombosis and Haemostasis (ISTH) major bleeding(Up to 30 months)
研究者
Dr Shekhar Dawkhar
Fortrea Development India Private Limited
研究点 (39)
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