EUCTR2012-001814-41-AT进行中（未招募）不适用
A prospective, randomized, controlled, analyst-blinded, parallel group study to investigate the effect of antithrombotic triple therapy with ticagrelor and acetylsalicylic acid in combination with dabigatran or rivaroxaban or phenprocoumon on markers of coagulation activation in venous and shed blood in healthy male subjects - Antithrombotic triple therapy
Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie0 个研究点目标入组 60 人开始时间: 2012年4月30日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Healthy male subjects; 18 – 40 years of age
- •body mass index between 18 and 27 kg/m2
- •Written informed consent
- •Normal findings in medical & bleeding history
- •Non-smoking behaviour
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Regular intake of any medication including OTC drugs within 2 weeks before IMP administration
- •Known coagulation disorders (e.g. haemophilia, von Willebrand´s disease)
- •Known disorders with increased bleeding risk (e.g. peridontosis, haemorrhoids, acute gastritis, peptic ulcer, intestinal ulcer)
- •Known sensitivity to common causes of bleeding (e.g. nasal)
- •History of thromboembolism
- •Impaired liver function (AST, ALT, GGT >3 x ULN, Bilirubin >2 x ULN)
- •Impaired renal function (serum creatinine > 1.3 mg/dl)
- •Any other relevant deviation from the normal range in clinical chemistry, haematology or urine analysis
- •HIV-1/2-Ab, HbsAg or HCV-Ab positive serology
- •Systolic blood pressure below 100 mmHg or above 145 mmHg, diastolic blood pressure above 95 mmHg
- •Known allergy against test agents
- •Regular daily consumption of more than on litre of xanthine-containing beverages or more than 40g alcohol
- •Participation in another clinical trial during the preceding 3 weeks
研究者
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