Drotrecogin Alfa (Activated) (LY203638)] Exploratory, Safety Study, Multi-Center, Randomized, Placebo-Controlled, Dose Escalating Study Design, Comparing a Standard Therapy (Enoxaparin Sodium) for Submassive Pulmonary Embolism to a Combined Therapy of Drotrecogin Alfa (Activated) Plus Enoxaparin Sodium.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Number of Participants With Major Bleeding Events
研究概览
简要总结
An exploratory, multicenter, randomized, placebo-controlled, double blind, dose escalation study comparing a standard therapy for submassive pulmonary embolism (Enoxaparin sodium) to a combined therapy of Drotrecogin alfa (activated) plus Enoxaparin sodium.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical symptoms of Pulmonary embolism for less than 48 hours
排除标准
- •Patients with symptoms of Pulmonary embolism for more than 48 hours
研究组 & 干预措施
1
干预措施: Drotrecogin Alfa (Activated) (Drug)
1
干预措施: Enoxaparin (Drug)
2
干预措施: Enoxaparin (Drug)
2
干预措施: Drotrecogin Alfa (Activated) (Drug)
3
干预措施: Enoxaparin (Drug)
3
干预措施: Drotrecogin Alfa (Activated) (Drug)
4
干预措施: Enoxaparin (Drug)
4
干预措施: Drotrecogin Alfa (Activated) (Drug)
5
干预措施: Enoxaparin (Drug)
5
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Major Bleeding Events
时间窗: baseline through day 6
Number of patients with major bleeding events, defined as: Reduction in hemoglobin of 2 to 5 grams per deciliter (g/dL) within 24 hours; Transfusion of 2 to 4 units of packed red blood cells within 24 hours; Hematoma requiring prolonged hospitalization or surgical intervention; Intracranial or retroperitoneal hemorrhage.
次要结局
- Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios(baseline, day 6, day 90)
- Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada)(baseline and day 90 (follow-up))
- Difference in Pulmonary Artery (PA) Pressure(baseline, day 6, day 90)