Preventing lifelong changes and complaints of the leg after a clot has formed in the vein of the leg with an additional medincine

Phase 1

• Conditions: Post-thrombotic syndrome; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-000749-15-NL
• Lead Sponsor: Academisch ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-18
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

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

?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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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? <br><br>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?<br><br>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 Outcome Measures

Name	Time	Method
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) <br><br>- 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) <br><br>- Scores on PTS-characterizing symptoms of the affected leg (pain, cramps, heaviness, paresthesia, pruritus) <br><br>- 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.<br>- at baseline, 1 week, 4 weeks, 8 weeks and 12 weeks after DVT.<br>- at baseline, 4 weeks and 12 weeks after DVT.<br>- at baseline, 4 weeks and 12 weeks.