NCT01561950终止1 期
Use of Recombinant FVIIa to Mitigate Clopidogrel Anti-platelet Therapy-Mediated Bleeding in a Single Centre, Randomized, Placebo-controlled, Double-blind Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Bleeding duration measured in minutes
研究概览
简要总结
This trial is conducted in the United States of the America (USA). The aim of this trial is to evaluate the effectiveness of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with clopidogrel (Plavix®).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •PT/PTT within normal laboratory range (e.g., PT: 9.4-12.0)
- •Platelet count within normal laboratory range
排除标准
- •The receipt of any investigational drug within 1 month prior to this trial
- •Use of anticoagulation therapy-defined as vitamin K antagonists, platelet antagonists, heparin
- •(or low molecular weight heparin), aspirin or NSAIDs (non-steroidal anti-inflammatory drug) within 30 days prior to trial
- •African-American race
- •Weight above or equal to 160 kg
研究组 & 干预措施
Factor VII
Experimental
干预措施: eptacog alfa (activated) (Drug)
Factor VII
Experimental
干预措施: clopidogrel (Drug)
Placebo
Placebo Comparator
干预措施: clopidogrel (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Bleeding duration measured in minutes
时间窗: From onset of bleeding till the end of the bleeding
次要结局
- Blood volume reported in millilitres(From onset of bleeding till the end of the bleeding)
- Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes(Time to onset of clot formation)
- Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes(Time to achieve 20 mm clot strength)
- Adverse events, including thrombotic events(From screening to day 11-18)
- Change in coagulation-related parameters after pre-biopsy(From baseline to 15 minutes after pre-biopsy)
- Change in coagulation-related parameters after biopsy B2(From baseline to 3 hours after B2)
- Change in coagulation-related parameters after biopsy B3(From baseline to 1 hour after B3)
研究者
研究点 (1)
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