2023-503224-66-00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)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,365
- 试验地点
- 219
- 主要终点
- The primary efficacy endpoint is the time to first occurrence of confirmed ischemic stroke or SE.
研究概览
简要总结
To assess whether abelacimab is superior to placebo for reducing the risk of ischemic stroke or SE in patients with AF who have been deemed unsuitable for oral anticoagulation therapy
研究设计
- 分配方式
- Randomized
- 主要目的
- Abelacimab 150mg or placebo
- 盲法
- Double (Investigator, Monitor, Subject)
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient is able to understand and has provided written informed consent to participate in the trial
- •Diagnosed AF or atrial flutter (documented on an ECG or monitor recording)
- •Age 65-74 and CHA2DS2VASc ≥4 OR age ≥75 and CHA2DS2VASc ≥3
- •Patient is judged by the responsible physician to be unsuitable for oral anticoagulation because the risks outweigh the benefits or the patient is unwilling to take oral anticoagulation AND this determination was made prior to and independent of this study
- •At least 1 of the following: ⎯ Severe renal insufficiency (creatinine clearance <30 mL/min by the Cockcroft-Gault formula) ⎯ Planned daily use of aspirin, a P2Y12 inhibitor, or other antiplatelet agent for the duration of the trial ⎯ History of bleeding from a critical area (such as intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome) or major gastrointestinal bleeding ⎯ Other conditions associated with an increased risk of bleeding such as chronic NSAID use (≥3 times per week); frailty; or history of multiple falls"
- •Patient is judged by the responsible physician to be unsuitable for left atrial appendage (LAA) closure or occlusion device, an approved device is not available, or the patient is unwilling to undergo the procedure AND this determination was made prior to and independent of the study
排除标准
- •AF due to an ongoing acute reversible cause (e.g., cardiac surgery, PE, untreated hyperthyroidism, alcohol use)
- •Any stroke within 14 days before randomization or 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
- •Patients with a medical condition other than AF for which chronic anticoagulation is indicated
- •Known presence of an atrial myxoma or left ventricular thrombus
- •History of or planned LAA closure or occlusion device
- •Clinically unstable or active endocarditis or endovascular infection
- •Any patients who are committed to an institution by either judicial or administrative authorities.
- •Planned invasive procedure with potential for uncontrolled bleeding (e.g., major surgery) within the next 3 months
- •Patients on dialysis at screening or who are planned to start dialysis within 6 months
- •Use of other investigational drugs within 5 half-lives prior to enrollment or until the expected pharmacodynamic effect has returned to baseline, whichever is longer
- •History of hypersensitivity to any of the study drugs or its excipients, to drugs of similar chemical classes
- •Women of child-bearing potential defined as all women physiologically capable of becoming pregnant.
- •Any medical or psychiatric condition which in the judgment of the Investigator may preclude patients from complying with study requirements for the duration of the study.
- •Patients who within 60 days prior to randomization (1) received a vitamin K antagonist [(VKA) e.g., warfarin phenprocoumon, acenocoumarol] or a direct oral anticoagulant (DOAC) such as dabigatran, rivaroxaban, apixaban, or edoxaban or (2) were newly diagnosed with AF
- •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
结局指标
主要结局
The primary efficacy endpoint is the time to first occurrence of confirmed ischemic stroke or SE.
The primary efficacy endpoint is the time to first occurrence of confirmed ischemic stroke or SE.
The primary safety endpoint is the time to first occurrence of adjudicated BARC type 3c/5 bleeding. Other safety endpoints include: • ISTH major bleeding • BARC type 3b/3c/5 bleeding • ISTH major and clinically relevant nonmajor (CRNM) bleeding • All bleeding"
The primary safety endpoint is the time to first occurrence of adjudicated BARC type 3c/5 bleeding. Other safety endpoints include: • ISTH major bleeding • BARC type 3b/3c/5 bleeding • ISTH major and clinically relevant nonmajor (CRNM) bleeding • All bleeding"
次要结局
- The secondary efficacy endpoints include: • Composite of ischemic stroke, SE, MI, VTE, or acute limb ischemia • Composite of ischemic stroke, SE, or BARC type 3c/5 bleeding • Cardiovascular (CV) mortality • All-cause mortality • Composite of ischemic stroke, SE, MI, VTE, acute limb ischemia, or ISTH major bleeding"
研究者
Information Desk
Scientific
Anthos Therapeutics Inc.
研究点 (219)
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