NCT00244504终止3 期
The Effects of Small Doses of Moxonidine in Patients Undergoing Vascular Surgery
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2002年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- over-all mortality
研究概览
简要总结
Investigating the perioperative effect of moxonidine. In a randomized double-blind fashion, patients undergoing vascular surgery will receive moxonidine 0.2 mg or placebo from the day before surgery until day 4 after surgery. Holter-EKG for 48 h, starting just before surgery. Repeated 12-lead EKG, measurements of Troponin I and BNP, clinical visitations, follow-up interviews at 6 and 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •abdominal aortic or peripheral vascular surgery
排除标准
- •unstable angina,
- •severe symptomatic heart failure (NYHA IV)
- •systolic blood pressure at rest < 100 mmHg
- •bradycardia (<50/min)
- •higher grade AV heart block
- •creatinine clearance < 30 ml/min
- •pregnancy
- •no consent
研究组 & 干预措施
I
Active Comparator
moxonidine group
干预措施: moxonidine (Drug)
II
Placebo Comparator
placebo group
干预措施: moxonidine (Drug)
结局指标
主要结局
over-all mortality
时间窗: 30 days and 12 months
次要结局
- Ischemia detected by Holter-ECG ST alterations or troponin T elevation(7 days)
研究者
研究点 (1)
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