DRKS00004652已完成2 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: 2013年2月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Secured diagnosis of livedoid vasculopathy
- •2. Age = 18 < 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
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. Not adjusted, severe arterial hypertension (stage 3)
- •10. Artificial heart valves
- •11. Acute pulmonary embolism
- •12. Bronchiectasis or pulmonary blood flow in the anamnesis
- •13. Known vascular retinopathy
- •14. Intracranial or intracerebral hemorrhage within the last 30 days prior to initiation of therapy or during trial progress
- •15. Operations on the brain, spinal cord or eye within the last 30 days prior to initiation of therapy or during trial progress
- •16. Spinal / epidural anesthesia or puncture within 2 weeks prior to treatment or during trial progress
- •17. Application of systemic heparin within 7 days prior to treatment
- •18. Taking NSARs or inhibitor of platelet aggregation within 7 days prior to treatment or during trial progress
- •19. Application of vitamin K antagonists (marcumar, warfarin) and / or thrombin inhibitor (dabigatran) within 7 days prior to treatment or during trial progress
- •20. Concomitant administration of CYP3A4 inductors (eg, rifampicin, phenytoin, carbamazepine, phenobarbital and St. John's Wort)
- •21. Concomitant systemic treatment with azole-antifungals (such as ketoconazole, itraconazole, voriconazole and posaconazole)
- •22. Concomitant systemic treatment with HIV protease inhibitors (eg, ritonavir)
- •23. Concomitant systemic treatment with dronedarone
研究者
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