NCT02140372已完成4 期
Anti-platelet Effects of Colchicine in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Monocyte Platelet Aggregate: 2 Hours
研究概览
简要总结
This is a pilot study. Volunteers will be given 1.8 mg (1.2 mg followed by 0.6 mg one hour later), 1.2 mg, or 0.6 mg of colchicine. Blood will be collected prior to drug administration, 2 hours after colchicine administration, and 24 hours after colchicine administration via the antecubital vein and evaluated for markers of platelet activity and inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be more than 18 years of age
排除标准
- •history of cardiovascular disease, including myocardial infarction, history of percutaneous coronary angioplasty or stent, peripheral vascular disease or stroke; 2) history of myelodysplasia; 3) medications known to affect platelet function, including non-steroidal anti-inflammatory drugs, antihistamines, and selective serotonin reuptake inhibitors, during the 5 days prior to participation; 4) medications known to interact with colchicine; 5) history of intolerance to colchicine; 6) acute or chronic symptoms of diarrhea, nausea, or vomiting within 1 month prior to enrollment; 7) known anemia or hemoglobin <10mg/dL; 8) platelet count <100,000 or > 450,000; 9) creatinine clearance <30cc/minute; 10) any known hemorrhagic diathesis; 11) pregnant; 12) Unable to consent; or 13) Participating in a competing study.
研究组 & 干预措施
Volunteer group
Experimental
Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later
干预措施: Colchicine (Drug)
结局指标
主要结局
Monocyte Platelet Aggregate: 2 Hours
时间窗: 2 Hours
Monocyte Platelet Aggregate: Baseline
时间窗: Baseline
次要结局
- Light Transmission Aggregometry: 2 Hours(2 hours)
- Platelet Adhesion: Baseline(Baseline)
- Light Transmission Aggregometry: Baseline(baseline)
- Platelet Adhesion: 2 Hours(2 hours)
研究者
研究点 (1)
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