A phase II multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS)
- Conditions
- livedoid vasculopathyL95.0Livedoid vasculitis
- Registration Number
- DRKS00004652
- Lead Sponsor
- niversitätsklinikum Münster
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 28
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of local pain on the VAS; intraindividual difference of two<br>values on the VAS between baseline (before) and after 12 weeks<br>(after)
- Secondary Outcome Measures
Name Time Method 1) Assessment of local pain on the VAS; intraindividual difference of<br>values on VAS between baseline (before) and after 4 weeks<br>2) Assessment of local pain on the VAS; intraindividual difference of<br>values on VAS between baseline (before) and after 8 weeks<br>3) Assessment (DLQI); intraindividual difference of values between<br>baseline (before) and after 4 weeks<br>4) Assessment (DLQI); intraindividual difference of values between<br>baseline (before) and after 8 weeks<br>5) Assessment (DLQI); intraindividual difference of values between<br>baseline (before) and after 12 weeks (after)<br>6) Consumption of rescue medication