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

NCT03050138 | Completed

• 1 other identifier: 2014/151
• Study Type: observational
• Target: 351
• Locations: 3 countries
• Sites: 3

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

Conditions

Postthrombotic Syndrome

Keywords

Postthrombotic Syndrome; Venous Thrombosis; Quality of Life; Hemorrhage; Recurrence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Recurrent venous thromboembolism

  April 2016 - December 2017

• Post-thrombotic syndrome (PTS) determined by the standard Villalta score

  April 2016 - December 2017

• Generic health related Quality of Life (HRQoL)

  April 2016 - December 2017

• Disease specific health related Quality of Life (HRQoL)

  April 2016 - December 2017

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients who refuse to participate
• Deceased patients

Sponsors & Collaborators

• Oslo University Hospital: lead
• Ostfold Hospital Trust: collaborator
• St. Olavs Hospital: collaborator
• Vestre Viken Hospital Trust: collaborator
• Sahlgrenska University Hospital: collaborator
• Kristianstad University: collaborator
• Jewish General Hospital: collaborator
• McMaster University: collaborator

Study Sites (3)

Hamilton Health Sciences Corporation

Hamilton, Ontario, L8L8E7, Canada

Location

Oslo University Hospital Rikshospitalet

Oslo, 0424, Norway

Location

Sahlgrenska Universitetssjukhuset/Östra

Gothenburg, 413 45, Sweden

Location

Related Publications (3)

• 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):361-367. doi: 10.1160/th15-04-0318. Epub 2015 Sep 17.

  PMID: 26422814 BACKGROUND

• 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.

  PMID: 19966341 BACKGROUND

• 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.

  PMID: 24344086 BACKGROUND

MeSH Terms

Conditions

Postthrombotic Syndrome; Venous Thrombosis; Hemorrhage; Recurrence

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Hilde S Wik, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant in hematology

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 10, 2017
• Study Start: April 1, 2016
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); SE (1); CA (1)