Trial document




drksid header

  DRKS00004652

Trial Description

start of 1:1-Block title

Title

A phase II multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Riliva

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Livedoid vasculopathy or livedo vasculitis is a rare chronic recurrent disease of the skin, which is characterized by the formation of blood clots in the cutaneous microcirculation.
The disease occurs almost exclusively in the ankle and on the back of the foot and the lower part of the leg.
The consequence is a reduced perfusion of the affected skin area which eventually leads to necrosis and scarring. This process is accompanied by severe pain and an impaired quality of life.
The investigational drug "Rivaroxaban" is an anticoagulant.
It is expected that by the administration of Rivaroxaban there is an increase of cuatenous blood supply and inhibition of further skin necrosis.
Potential study participants are patients with the confirmed diagnosis of vasculopathy aged 18-80 years.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Livedoid vasculopathy or Livedo vasculitis is a rare chronic recurrentdisease of the skin, which is characterized by recurrent thrombus formation in the dermal microcirculation. The disease occurs almost exclusively in the malleolar region and on the back of the foot and the distal lower leg.

Histological studies of skin biopsies of livedoid vasculopathy patients show occluding fibrin deposits on the vessel wall and in the lumen of the dermal microcirculation. The occlusions are found especially in the small vessels of the middle and upper dermis, which allow the blood supply to the upper skin. The occlusion of these vessels leads to insufficient perfusion and supply of the dependent skin area and triggers a strong pain signal. The reduced blood flow (ischemia) results in a so-called angina cutis, which leads - if left untreated - to skin infarctions. The tissue death in the absence of blood flow is then visible as necrosis and ulceration of the skin.

The continuous use of anticoagulants leads to an improvement of the clinical situation. The underlying causes for cutaneous infarctions are heterogeneous, but ultimately follow the known mechanisms of the coagulation cascade.

Rivaroxaban affects the coagulation cascade and prevents the blocking of the factor Xa-dependent conversion of prothrombin to thrombin. Thus, the risk of thrombosis is reduced significantly.

It is expected that this form of oral therapy results in a prevention of further skin infarctions and increases the quality of life of patients suffering from livedoid vasculopathy.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004652
  •   2013/02/07
  •   2012/12/27
  •   yes
  •   Approved
  •   2012-572-f-A, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1138-5805 
  •   2012-000108-13 
  •   EUTCR2012-000108-13-DE  (EU Clinical Trials Register )
  •   4038652 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   livedoid vasculopathy
  •   L95.0 -  Livedoid vasculitis
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Daily one tablet 10 mg Xarelto (rivaroxaban) in the morning and one tablet in the evening, orally with a meal, over a treatment period of 12 weeks.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IIa
  •   Yes
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Assessment of local pain on the VAS; intraindividual difference of two
values on the VAS between baseline ("before") and after 12 weeks
("after")

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/12/28
  •   20
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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. 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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Münster
    • Albert-Schweizer-Campus 1
    • 48149  Münster
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Münster Klinik und Poliklinik für Hautkrankheiten
    • Mr.  PD Dr. med.  Tobias  Goerge 
    • Von-Esmarch-Str. 58
    • 48149  Münster
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Münster Klinik und Poliklinik für Hautkrankheiten
    • Mr.  PD Dr. med.  Tobias  Goerge 
    • Von-Esmarch-Str. 58
    • 48149  Münster
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bayer Vital GmbH Bayer HealthCare Pharmaceuticals
    • 51368  Leverkusen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/09/11
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.