Effects of Combinated Administration of Lysine Acetylsalicylate Versus Prasugrel and Aspirin on Platelet Aggregation in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Inhibition of platelet aggregation
研究概览
简要总结
This is a phase I clinical trial in healthy volunteers comparing the effect of lysine acetylsalicylate or aspirin on platelet function.
详细描述
- SUMMARY 1.1. Type of trial Phase I clinical trial in healthy volunteers and marketed drugs 1.2. Identification of the promoter (correspondence to) Dr. David Vivas Balcones Cardiology Department Hospital Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid Phone: +34 91 330 31 49 Fax: +34 913303142 Email: dvivas@secardiologia.es 1.3. Clinical trial title Effect of combined administration of prasugrel and lysine acetylsalicylate intravenously versus prasugrel and aspirin on platelet aggregation in healthy volunteers (ECCLIPSE trial).
1.4. Protocol code Nº EudraCT: 2012-001702-20 Code: 2012-ECCLIPSE-01 Version: V3 Date: 13/04/2012
1.5. Project principal investigator Dr. David Vivas Balcones Cardiology Department Hospital Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid Phone: +34 91 330 31 49 Fax: +34 913303142 Email: dvivas@secardiologia.es 1.6. Centers Investigators
San Carlos University Hospital (Madrid). Within the following services and researchers are involved:
Cardiology Department Hospital Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid Teléfono: +34 91 330 31 49 Fax: +34 913303142 Project principal investigator and Promoter: Dr. David Vivas Balcones Co-Investigators: Dr. Agustín Martín, Dr. Isidre Vilacosta, Dr. Iván Núñez-Gil y Dr. Carlos Macaya
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-60 years.
- •BMI> 19kg/m2 and <29kg/m
- •Women of childbearing potential who are committed to use a medically effective contraception during their participation in the study, except hormonal contraceptives.
- •Percentage of inhibition of platelet aggregation after stimulation with high basal 20 mM ADP and arachidonic acid 1.5 mM> 70%.
- •No clinically significant deviation on physical examination, ECG or laboratory values in laboratory tests.
- •Signed informed consent
排除标准
- •Drug abuse
- •Pregnant or lactating
- •Infection with Hepatitis B or C, or HIV
- •Known drug allergies
- •Family history of blood disorders or coagulation.
- •History of disease that alters the absorption, metabolism or excretion of drugs, including jaundice.
- •Personal history of bleeding and / or blood dyscrasias (especially hemophilia, hypoprothrombinemia), including vascular malformations reasonable suspicion.
- •History of any medically relevant condition
- •Background of major surgery in the last 3 months
- •Prescription of chronic medication in the 14 days prior to study participation.
- •Participation in another study involving the administration of an investigational product in the last 4 months or a product already on the market in the last three months.
研究组 & 干预措施
prasugrel and acetylsalicylic
single dose of prasugrel 60 mg orally and 300 mg acetylsalicylic acid orally
干预措施: acetylsalicylic acid (Drug)
prasugrel and acetylsalicylic
single dose of prasugrel 60 mg orally and 300 mg acetylsalicylic acid orally
干预措施: prasugrel (Drug)
lysine acetylsalicylate and prasugrel
single dose of prasugrel 60 mg oral and lysine acetylsalicylate 450 mg intravenous
干预措施: prasugrel (Drug)
lysine acetylsalicylate and prasugrel
single dose of prasugrel 60 mg oral and lysine acetylsalicylate 450 mg intravenous
干预措施: lysine acetylsalicylate (Drug)
结局指标
主要结局
Inhibition of platelet aggregation
时间窗: at 30 minutes
measured by light transmission aggregometry
次要结局
- Inhibition of platelet aggregation(baseline, 1 h, 4 h and 34 h)
- Incidence of adverse events(baseline, 30 min, 1 h, 4 h, and 24 h)
- Inhibition of platelet reactivity(baseline, 1 h, 4 h and 34 h)
研究者
David Vivas
MD, PhD
Fundacion Investigacion Interhospitalaria Cardiovascular