Evaluation of MST-188 in Acute Lower Limb Ischemia: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial Evaluating the Safety and Efficacy of MST-188 in Subjects With Acute Lower Limb Ischemia Receiving Catheter-Directed Recombinant Tissue Plasminogen Activator
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Angiographic assessment of the change in the volume of thrombus (Exploratory endpoint)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of MST-188 in subjects receiving catheter-directed rt-PA for acute lower limb ischemia and to evaluate whether treatment with MST-188 results in more rapid thrombolysis of the occlusion and more rapid tissue perfusion in the effected blood vessel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥30 to <80
- •Symptoms consistent with ALI in target lower limb classified as Rutherford Category IIa or IIb
- •Subject is hospitalized or in the process of hospitalization for the treatment of ALI
- •Angiographic confirmation of thrombotic lower limb arterial occlusion
排除标准
- •Prosthetic bypass graft occlusion within 1 month of implantation or autogenous graft occlusion within 6 months of placement
- •Treatment with a thrombolytic agent within the last 48 hours
- •Subject's laboratory results indicate inadequate organ function
- •NYHA Class IV congestive heart failure
- •Prior major amputation of the target limb
- •Other complications or contraindications for receiving rt-PA, anticoagulants, or contrast media
研究组 & 干预措施
Saline
Saline administered IV for 12 hours
干预措施: Saline (Drug)
Lower Dose
MST-188 loading dose 100 mg/kg IV for 1 hour followed by 25 mg/kg/hr for 11 hours
干预措施: MST-188 (Drug)
Higher Dose
MST-188 loading dose 200 mg/kg IV for 1 hour followed by 75 mg/kg/hr for 11 hours
干预措施: MST-188 (Drug)
结局指标
主要结局
Angiographic assessment of the change in the volume of thrombus (Exploratory endpoint)
时间窗: Baseline, 8 and 24 hours
Assessment of the change in TcPO2 (Exploratory endpoint)
时间窗: Baseline, 8, 12, and 24 hours
Number of participants with adverse events
时间窗: Randomization through 30 days post-treatment
次要结局
未报告次要终点