EUCTR2012-000108-13-DE进行中（未招募）1 期
A phase II multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS) - Riliva
niversitätsklinikum Münster0 个研究点目标入组 28 人开始时间: 2012年11月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
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
- All
入选标准
- •1) Secured livedo vasculopathy
- •2) Age = 18 years and = 80 years
- •3) 40 points on the pain VAS at least one day within the last 7 days before beginning therapy
- •4) No participation in another intervention study within the last 30 days before beginning therapy
- •5) Adequate communication skills in the German language
- •6) Patient must be able to recognize the nature, significance and scope of the clinical trial and to align his will hereafter
- •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 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1) Known allergy to the study medication
- •2) Known problems of galactose intolerance, deficit of lactase or glucose-galactose malabsorption
- •3) Pregnancy
- •4) In women: unsecured contraception (Requirement: Pearl Index <1)
- •5) Lactation
- •6) Known renal impairment (creatinine clearance <30ml/min)
- •7) Known liver disease (Child-Pugh score B and C)
- •8) Known ulcerative gastrointestinal disorders within the last 30 days prior to initiation of therapy or during
- •9) Uncontrolled, severe arterial hypertension
- •10) Artificial heart valves
- •11) Acute pulmonary embolism
- •12) Known bronchiectasis or pulmonary bleeding
- •13) Known vascular retinopathy
- •14) Intracranial or intracerebral haemorrhage within the last 30 days before beginning of therapy or during therapy
- •15) Brain, spinal cord or eye surgery within the last 30 days before beginning of therapy or during therapy
- •16) Spinal or epidural anaesthesia or puncture within the last 2 weeks before beginning of therapy or during therapy
- •17) Application of systemic heparin within 1 day before beginning of therapy
- •18) Intake of NSARs or thrombocyte aggregation inhibitors within 1 day before beginning of therapy or during therapy
- •19) Intake of vitamin-K-antagonists (marcumar, warfarin) and/or thrombin inhibitor (dabigatran) within 7 days before beginning of therapy or during therapy
- •20) Concomitant use of CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital or St. John’s Wort)
- •21) Concomitant systemic treatment with
- •azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole)
- •22) Concomitant systemic treatment with HIV-protease inhibitors (e.g. ritonavir)
- •23) Concomitant systemic treatment with dronedarone
- •24) Presence of malignant neoplasms at high risk of bleeding
- •25) Recent brain or spinal injury
- •26) Known or suspected oesophageal varices
- •27) Known arteriovenous malformations
- •28) Known vascular aneurysms
- •29) Known major intraspinal or intracerebral vascular abnormalities
研究者
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