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

Postthrombotic Syndrome Clinical Trial

— DABI-PTS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050138
• Other study ID #: 2014/151
• Status: Completed
• Start date: April 2016
• Est. completion date: January 31, 2019

Study information

• Verified date: April 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Syndrome
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences Corporation	Hamilton	Ontario
Norway	Oslo University Hospital Rikshospitalet	Oslo
Sweden	Sahlgrenska Universitetssjukhuset/Östra	Gothenburg

Sponsors (8)

Lead Sponsor	Collaborator
Oslo University Hospital	Jewish General Hospital, Kristianstad University, McMaster University, Ostfold Hospital Trust, Sahlgrenska University Hospital, Sweden, St. Olavs Hospital, Vestre Viken Hospital Trust

Countries where clinical trial is conducted

Canada,  Norway,  Sweden, 

References & Publications (3)

Schulman S, Kakkar AK, Goldhaber SZ, Schellong S, Eriksson H, Mismetti P, Christiansen AV, Friedman J, Le Maulf F, Peter N, Kearon C; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014 Feb 18;129(7):764-72. doi: 10.1161/CIRCULATIONAHA.113.004450. Epub 2013 Dec 16. — View Citation

Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Baanstra D, Schnee J, Goldhaber SZ; RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009 Dec 10;361(24):2342-52. doi: 10.1056/NEJMoa0906598. — View Citation

Utne KK, Ghanima W, Foyn S, Kahn S, Sandset PM, Wik HS. Development and validation of a tool for patient reporting of symptoms and signs of the post-thrombotic syndrome. Thromb Haemost. 2016 Jan;115(2):361-7. doi: 10.1160/TH15-04-0318. Epub 2015 Sep 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-thrombotic syndrome (PTS)	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.	April 2016 - December 2017
Secondary	Recurrent venous thromboembolism	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.	April 2016 - December 2017
Secondary	Post-thrombotic syndrome (PTS) determined by the standard Villalta score	Prevalence of PTS determined by the standard Villalta score in a subgroup of patients in the two treatment arms of the RE-COVER studies.	April 2016 - December 2017
Secondary	Generic health related Quality of Life (HRQoL)	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.	April 2016 - December 2017
Secondary	Disease specific health related Quality of Life (HRQoL)	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.	April 2016 - December 2017