Resolution Enhancement by a Supplemental Obstruction Lessening Venoactive Drug for Eight Weeks in Deep Vein Thrombosis

NCT04670432 | Completed Phase 3

• 1 other identifier: NL73142.068.20
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The RESOLVE-DVT study is a randomized single-center pilot study to determine the effects of hydroxyethylrutoside (Venoruton) on aspects of deep vein thrombosis (DVT) resolution associated with post-thrombotic syndrome (PTS). Based on these results, the investigators will estimate its potential as a preventive therapy for PTS. Eligible consenting patients who develop an acute, objectively confirmed DVT will be randomized and equally allocated to two trial arms, either the treatment group (Venoruton tablet 500 mg twice daily) or the control group (usual care). The pilot trial consists of 5 study contacts over 12 weeks at which outcome assessment is performed: inclusion, 1 week, 4 weeks, 8 weeks, 12 weeks. Treatment allocation is masked for outcome assessors, but not for patients.

Conditions

Deep Vein Thrombosis

Keywords

Venoactive drugs; Hydroxyethylrutoside; Venoruton; Thrombus resolution; Residual Vein Obstruction; Post-Thrombotic Syndrome

Outcome Measures

Primary Outcomes (1)

• Residual Vein Obstruction

  Transversal vein diameter ≥2mm on duplex-ultrasound during full compression, which is assessed by a radiologist blinded for study allocation. A secondary assessment based on acquired images will be performed by an independent expert radiologist, again blinded for study allocation.

  At 12 weeks

Secondary Outcomes (6)

• Levels of circulating biomarkers

  At time of inclusion, 1 week, 4 weeks, 8 weeks and 12 weeks

• Clinical sign severity

  At time of inclusion, 1 week, 4 weeks, 8 weeks and 12 weeks

• Symptom severity

  At time of inclusion, 4 weeks and 12 weeks

• VEINS Quality of Life/Symptoms (VEINES-QOL/Sym)

  At time of inclusion, 4 weeks and 12 weeks

• Short Form 36 Health Survey (SF-36)

  At time of inclusion, 4 weeks and 12 weeks

Other Outcomes (5)

• Medication adherence

  At 1 week, 4 weeks, 8 weeks and 12 weeks

• Adherence to elastic compression therapy

  At 1 week, 4 weeks, 8 weeks and 12 weeks

• Pill counts Venoruton

  At 8 weeks, which is the end of Venoruton treatment

Study Arms (2)

Treatment group

EXPERIMENTAL

Hydroxyethylrutoside oral tablet twice daily for 8 weeks starting at the time of randomization, in addition to usual care.

Drug: Hydroxyethylrutoside

Control group

NO INTERVENTION

Usual care, consisting of anticoagulant treatment and elastic compression therapy for full study duration.

Interventions

Hydroxyethylrutoside DRUG

500 mg film-coated tablet

Also known as: Venoruton

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult, defined as ≥ 18 years of age
• Objectively confirmed DVT by DUS
• Proximal DVT, defined as iliofemoropopliteal venous thrombosis
• Acute DVT, defined as having symptoms for ≤ 7 days at presentation
• Willing and able to give written informed consent

You may not qualify if:

• Previous DVT
• Bilateral DVT
• Pre-existent chronic venous insufficiency (CEAP-criteria C ≥ 3)
• Active malignancy, inflammatory disease (e.g. rheumatoid arthritis), or immunosuppressive therapy
• Current pregnancy or breast feeding
• Indication for therapeutic thrombolysis
• Contra-indication for DOAC

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Netherlands Thrombosis Foundation: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (1)

• ten Cate-Hoek AJ, Henke PK, Wakefield TW. The post thrombotic syndrome: Ignore it and it will come back to bite you. Blood Rev. 2016 Mar;30(2):131-7. doi: 10.1016/j.blre.2015.09.002. Epub 2015 Oct 9.

  PMID: 26462885 BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis; Postthrombotic Syndrome

Interventions

Hydroxyethylrutoside; troxerutin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Intervention Hierarchy (Ancestors)

Rutin; Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Arina J ten Cate - Hoek, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: While patients are aware of their treatment allocation, the physicians (incl. radiologist) and researchers are not, as to provide unbiased outcome assessment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 17, 2020
• Study Start: December 8, 2020
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)