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Prevalence of Post-Thrombotic Syndrome in Deep-Vein Thrombosis (DVT) Patients Treated With Dabigatran

NCT03050138 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 351

Last updated 2019-04-11

No results posted yet for this study

Summary

The primary objective in this cross-sectional study is to assess the prevalence of post-thrombotic syndrome (PTS) in the two treatment arms of the RE-COVER studies (warfarin versus dabigatran). PTS will be assessed by the recently developed Patient Reported Villalta (PRV) Score.

Secondary objectives: to assess in both treatment arms the

1. Prevalence of recurrent venous thromboembolism (VTE) after the discontinuation of study treatment.
2. Prevalence of PTS determined by the standard Villalta score.
3. Health related Quality of Life (HRQoL).

Conditions

  • Postthrombotic Syndrome

Sponsors & Collaborators

  • Ostfold Hospital Trust

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Vestre Viken Hospital Trust

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Kristianstad University

    collaborator OTHER

  • Jewish General Hospital

    collaborator OTHER

  • McMaster University

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Hilde S Wik, MD, PhD · Oslo University Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • Canada
  • Norway
  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03050138 on ClinicalTrials.gov