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

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ClinicalTrials.gov Identifier: NCT03050138
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : April 11, 2019
Sponsor:
Collaborators:
Ostfold Hospital Trust
St. Olavs Hospital
Vestre Viken Hospital Trust
Sahlgrenska University Hospital, Sweden
Kristianstad University
Jewish General Hospital
McMaster University
Information provided by (Responsible Party):
Hilde Skuterud Wik, Oslo University Hospital

Study Description
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Brief 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).

Condition or disease
Postthrombotic Syndrome

Detailed Description:

In the RE-COVER- and RE-COVER II studies, 5109 patients with deep-vein thrombosis (DVT) and/or pulmonary embolism (PE) were randomized to receive 6 months of treatment with either dabigatran (150 mg twice daily) or warfarin (once daily to maintain international normalized ratio (INR) 2.0-3.0). All patients received an initial 5-7 day phase of parenteral anticoagulant treatment. The studies were designed as double blind, double dummy trials. RE-COVER was conducted between April 2006 to November 2008 and RE-COVER II between June 2008 and October 2010; they were completed in 2009 and 2011, respectively. A substantial number of patients are expected to have developed post-thrombotic syndrome (PTS). However, since dabigatran provides a stable level of anticoagulation throughout the treatment period and knowing that the quality of anticoagulation is an important factor in the development of PTS, we anticipate that a lower rate of PTS will be seen in the dabigatran treated patients compared to warfarin.

Patients will be interviewed and examined by the investigator if they accept to attend a clinic visit. Otherwise, a telephone interview will be performed if the patient refuses to meet up. PTS will be determined using Patient Reported Villalta (PRV) Score form. However, those who will meet for consultation will in addition be assessed for PTS by the standard Villalta score.

The primary endpoint will be the prevalence of PTS determined by Patient Reported Villalta (PRV) score. The secondary endpoints are 1- objectively verified DVT or PE after the discontinuation of treatment, 2- prevalence of PTS determined by the standard Villalta score, 3- health related quality of life (HRQOL) determined by EQ-5D (www.euroqol.org) and Venous Insufficiency Epidemiological and Economic Study quality of life and symptom (VEINES-QOL/Sym) questionnaires.

The investigators will recruit the subpopulation of patients who were included into the RE-COVER studies in the Norway, Sweden and Canada.

Study Design
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Study Type : Observational
Actual Enrollment : 351 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Prevalence of Post-Thrombotic Syndrome in Deep-Vein Thrombosis (DVT) Patients Treated With Dabigatran- a Cross-Sectional Assessment of RE-COVER Study Patients
Actual Study Start Date : April 2016
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Dabigatran
In the RE-COVER- and RE-COVER II studies, one group of DVT and/or PE patients were randomized to receive 6 months of treatment with dabigatran (150 mg twice daily). All patients received an initial 5-7 day phase of parenteral anticoagulant treatment.
Warfarin
In the RE-COVER- and RE-COVER II studies, the other group of DVT and/or PE patients were randomized to receive 6 months of treatment with warfarin (once daily to maintain international normalized ratio (INR) 2.0-3.0). All patients received an initial 5-7 day phase of parenteral anticoagulant treatment.


Outcome Measures
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Primary Outcome Measures :
  1. Post-thrombotic syndrome (PTS) [ Time Frame: April 2016 - December 2017 ]
    The primary objective is to assess the prevalence of PTS in a subgroup of patients in the two treatment arms of the RE-COVER studies assessed by Patient Reported Villalta (PRV) Score.


Secondary Outcome Measures :
  1. Recurrent venous thromboembolism [ Time Frame: April 2016 - December 2017 ]
    Prevalence of recurrent VTE after the discontinuation of study treatment in a subgroup of patients in the two treatment arms of the RE-COVER studies.

  2. Post-thrombotic syndrome (PTS) determined by the standard Villalta score [ Time Frame: April 2016 - December 2017 ]
    Prevalence of PTS determined by the standard Villalta score in a subgroup of patients in the two treatment arms of the RE-COVER studies.

  3. Generic health related Quality of Life (HRQoL) [ Time Frame: April 2016 - December 2017 ]
    Generic health related Quality of Life (HRQoL) assessed by the EQ-5D in a subgroup of patients in the two treatment arms of the RE-COVER studies.

  4. Disease specific health related Quality of Life (HRQoL) [ Time Frame: April 2016 - December 2017 ]
    Disease specific health related Quality of Life (HRQoL) assessed by the VEINES-QOL/Sym score in a subgroup of patients in the two treatment arms of the RE-COVER studies.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients participating in the RE-COVER- and RE-COVER II studies in Canada, Norway, Sweden, and Denmark will be invited to participate in this investigator initiated follow-up study. In the original studies patients with DVT and/or PE were randomized to receive 6 months of treatment with either dabigatran (150 mg twice daily) or warfarin (once daily to maintain international normalized ratio (INR) 2.0-3.0). All patients received an initial 5-7 day phase of parenteral anticoagulant treatment. The studies were designed as double blind, double dummy trials. RE-COVER was conducted between April 2006 to November 2008 and RE-COVER II between June 2008 and October 2010; they were completed in 2009 and 2011, respectively. The present study is a cross-sectional study.
Criteria

Inclusion Criteria:

  1. Patients with DVT (±PE) treated in the RE-COVER studies.
  2. Signed written informed consent.

Exclusion Criteria:

  1. Patients who refuse to participate
  2. Deceased patients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050138


Locations
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Canada, Ontario
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada, L8L8E7
Norway
Oslo University Hospital Rikshospitalet
Oslo, Norway, 0424
Sweden
Sahlgrenska Universitetssjukhuset/Östra
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
Oslo University Hospital
Ostfold Hospital Trust
St. Olavs Hospital
Vestre Viken Hospital Trust
Sahlgrenska University Hospital, Sweden
Kristianstad University
Jewish General Hospital
McMaster University
Investigators
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Principal Investigator: Hilde S Wik, MD, PhD Oslo University Hospital
More Information
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Publications:

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Responsible Party: Hilde Skuterud Wik, Senior consultant in hematology, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03050138    
Other Study ID Numbers: 2014/151
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hilde Skuterud Wik, Oslo University Hospital:
Postthrombotic Syndrome
Venous Thrombosis
Quality of Life
Hemorrhage
Recurrence
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Postthrombotic Syndrome
Postphlebitic Syndrome
Syndrome
Disease
Pathologic Processes
 Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases