Treatment of livedoid vasculopathy
Conditions
Interventions
Trade Name: Xarelto 10 mg
Product Name: Rivaroxaban
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIVAROXABAN
CAS Number: 366789-02-8
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Universitätsklinikum Münster
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 2) Assessment of local pain on the VAS; intraindividual difference of values ??on VAS between baseline ("before") and after 8 weeks 3) Assessment (DLQI); intraindividual difference of values ??between baseline ("before") and after 4 weeks 4) Assessment (DLQI); intraindividual difference of values ??between baseline ("before") and after 8 weeks 5) Assessment (DLQI); intraindividual difference of values ??between baseline ("before") and after 12 weeks ("after") 6) Consumption of rescue medication ;Timepoint(s) of evaluation of this end point: After 4, 8 and 12 weeks | — |
Countries
Germany
Contacts
Public ContactKlinik für Hautkrankheiten
Universitätsklinikum Münster
Outcome results
None listed