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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

351 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-01-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Postthrombotic Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group