NCT03398434撤回2 期
A Multicenter, Randomized, Open-label, Active-controlled, Dose-range Finding Study to Assess the Pharmacodynamic Parameters, Safety and Tolerability of MAA868 and Its Effect on Thrombogenesis Biomarkers Compared to Apixaban in Patients With Atrial Fibrillation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- number of patients achieving FXI inhibition ≥ 80% at trough after monthly dosing at 3 dose levels of MAA868 inhibition
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of MAA868 compared to apixaban in patients with atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
blinded (with majuscule) endpoint evaluation
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients ≥ 55 and < 85 years old
- •Body weight between 50 and 130 kg inclusive
- •Atrial fibrillation or atrial flutter, as documented by electrocardiography
- •CHA2DS2-VASc risk score ≥ 2 for male and female patients. Male patients with CHA2DS2VASc risk score of 1 can be included if anticoagulation therapy is warranted.
- •Either anticoagulant-naïve or receiving a stable treatment of a recommended dose of a new oral anticoagulant (NOAC) over the 8 weeks prior to screening.
排除标准
- •History of stroke, transient ischemic attack or systemic embolism
- •History of major bleeding during treatment with an anticoagulant or antiplatelet therapy in the last 12 months
- •History of traumatic or non-traumatic intracranial, intraspinal or intra-ocular bleeding
- •Known bleeding diathesis or any known active bleeding site at screening or baseline
- •Family history of bleeding disorder
- •Known active GI lesions predisposing to bleeding events
- •Myocardial infarction, unstable angina pectoris or coronary artery bypass graft (CABG) surgery within 12 months prior to the screening period
- •Known hemodynamically significant valvular heart disease
- •Uncontrolled hypertension defined as SBP/DBP ≥ 160/100 mmHg at the screening visit
- •Heart failure NYHA class IV in the 3 months prior to the screening visit
- •Dual antiplatelet therapy. Treatment with a P2Y12 inhibitor or low dose aspirin (≤ 100 mg/d) is allowed but not both.
- •Severe renal impairment (creatinine clearance < 30 mL/min) at the screening visit
研究组 & 干预措施
MAA868 low dose regimen
Experimental
patients receive dose monthly.
干预措施: MAA868 (Drug)
MAA868 middle dose regimen
Experimental
patients receive dose monthly.
干预措施: MAA868 (Drug)
MAA868 high dose regimen
Experimental
patients receive dose monthly.
干预措施: MAA868 (Drug)
Apixaban
Active Comparator
Apixaban 5 mg b.i.d
干预措施: Apixaban (Drug)
结局指标
主要结局
number of patients achieving FXI inhibition ≥ 80% at trough after monthly dosing at 3 dose levels of MAA868 inhibition
时间窗: month 3
Occurrence of achieving ≥ 80% inhibition of FXI (\< 20% free FXI) following 3 months of treatment.
次要结局
- number of patients achieving FXI inhibition ≥ 80% at trough after the first and second dose at 3 dose levels of MAA868(Month 1 and 2)
- Number of patients with incidence of major or clinically relevant non-major (CRNM) bleeding events during the treatment period.(day 1 to day 91)
- the effect of MAA868 on D dimer and other thrombogenesis biomarkers as indicators of efficacy compared to compotator(Days 31, 61 and 91)
研究者
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