Proof of concept, multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS)
- Conditions
- Treatment of livedoid vasculopathyTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2012-000108-13-DE
- Lead Sponsor
- niversitätsklinikum Münster
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 28
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the trial is the statistical evaluation of the therapeutic effects of rivaroxaban in patients with livedoid vasculopathy.;Secondary Objective: Secondary objectives of the trial are the evaluation of quality of life, patient safety and the consumption of rescue medication.;Primary end point(s): Assessment of local pain on the VAS; intraindividual difference of two values ??on the VAS between baseline (before) and after 12 weeks (after);Timepoint(s) of evaluation of this end point: After 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Assessment of local pain on the VAS; intraindividual difference of values ??on VAS between baseline (before) and after 4 weeks<br>2) Assessment of local pain on the VAS; intraindividual difference of values ??on VAS between baseline (before) and after 8 weeks<br>3) Assessment (DLQI); intraindividual difference of values ??between baseline (before) and after 4 weeks<br>4) Assessment (DLQI); intraindividual difference of values ??between baseline (before) and after 8 weeks<br>5) Assessment (DLQI); intraindividual difference of values ??between baseline (before) and after 12 weeks (after) <br>6) Consumption of rescue medication<br>;Timepoint(s) of evaluation of this end point: After 4, 8 and 12 weeks