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

Completed

• Conditions: Postthrombotic Syndrome

• Registration Number: NCT03050138
• Lead Sponsor: Oslo University Hospital

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).

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 Timeline

• Study Start: 2016-04
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-08
• Study First Posted: 2017-02-10
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-thrombotic syndrome (PTS)	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

Name	Time	Method
Post-thrombotic syndrome (PTS) determined by the standard Villalta score	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.
Recurrent venous thromboembolism	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.
Generic health related Quality of Life (HRQoL)	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.
Disease specific health related Quality of Life (HRQoL)	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.

Trial Locations

Locations (3)

Oslo University Hospital Rikshospitalet; 🇳🇴 Oslo, Norway

Sahlgrenska Universitetssjukhuset/Östra; 🇸🇪 Gothenburg, Sweden

Hamilton Health Sciences Corporation; 🇨🇦 Hamilton, Ontario, Canada