Post-thrombotic syndrome
Conditions
Interventions
Trade Name: Venoruton
Product Name: Venoruton
Pharmaceutical Form: Tablet
Sponsors
Academisch ziekenhuis Maastricht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Adult, defined as = 18 years of age ? Objectively confirmed DVT by duplex echography ? Proximal DVT, defined as an iliofemoropopliteal venous thrombosis ? Acute DVT, defined as having symptoms for = 7 days at presentation ? Willing and able to give written consent 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 44 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
Exclusion criteria: ? Previous DVT ? Bilateral DVT, since the unaffected leg is needed as a reference for clinical signs ? Pre-existent chronic venous insufficiency (CEAP-criteria C = 3), since this influences thrombus resolution ? Active malignancy, inflammatory disease (e.g. rheumatoid arthritis) and/or immunosuppressive therapy, since this will influence circulating inflammatory biomarkers ? Current pregnancy, since knowledge on the teratogenicity of the IMP is too limited ? Indication for therapeutic thrombolysis, since this influences thrombus resolution ? Contra-indication for DOAC, including reduced kidney function (eGFR < 30 ml/min/1,73 m2) and underweight (<50kg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: What is the effect of additional HR treatment for 8 weeks in combination with regular therapy on RVO after an acute, proximal DVT of the lower extremity?;Secondary Objective: What is the effect of additional HR treatment for 8 weeks in combination with regular therapy on PTS-associated circulating biomarkers after a first, acute, proximal DVT of the lower extremity? What is the effect of additional HR treatment for 8 weeks in combination with regular therapy on PTS-characterizing symptoms and clinical signs after a first, acute, proximal DVT of the lower extremity? What is the effect of additional HR treatment for 8 weeks in combination with regular therapy on quality of life after a first, acute, proximal DVT of the lower extremity?;Primary end point(s): Presence of RVO in proximal venous segments determined by echography ;Timepoint(s) of evaluation of this end point: at 12 weeks after DVT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Levels of circulating makers (e.g. hs-CRP, IL-6, IL-8, IL-10, TNF-a, ICAM-1, VCAM-1, P-selectin, FVIII, MMP-1, MMP-8) - Scores on PTS-characterizing clinical signs of the affected leg (circumferences, pitting-edema, hyperpigmentation, venous ectasia, redness, skin induration, pain during calf compression, venous ulcers) - Scores on PTS-characterizing symptoms of the affected leg (pain, cramps, heaviness, paresthesia, pruritus) - Scores on quality of life ;Timepoint(s) of evaluation of this end point: - at baseline, 1 week, 4 weeks, 8 weeks and 12 weeks after DVT. - at baseline, 1 week, 4 weeks, 8 weeks and 12 weeks after DVT. - at baseline, 4 weeks and 12 weeks after DVT. - at baseline, 4 weeks and 12 weeks. | — |
Countries
Netherlands
Contacts
Public ContactClinical Trial Center Maastricht
Maastricht University Medical Center
Outcome results
None listed