Postthrombotic SyndromeDABI-PTSNCT03050138
Prevalence of Post-Thrombotic Syndrome in Deep-Vein Thrombosis (DVT) Patients Treated With Dabigatran
An observational study of Postthrombotic Syndrome, run by Oslo University Hospital at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postthrombotic Syndrome
- How many people
- 351 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2016to 31 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with DVT (±PE) treated in the RE-COVER studies.
- Signed written informed consent.
Who cannot join
- Patients who refuse to participate
- Deceased patients
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
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
- Prevalence of recurrent venous thromboembolism (VTE) after the discontinuation of study treatment.
- Prevalence of PTS determined by the standard Villalta score.
- Health related Quality of Life (HRQoL).
Read the 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.
- Conditions
- Postthrombotic Syndrome
- Keywords
- Postthrombotic Syndrome, Venous Thrombosis, Quality of Life, Hemorrhage, Recurrence
- Medical subject headings
- Postthrombotic Syndrome, Venous Thrombosis, Hemorrhage, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: April 2016 - December 2017
Secondary outcomes (4)
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.
Measured: April 2016 - December 2017
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.
Measured: April 2016 - December 2017
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.
Measured: April 2016 - December 2017
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.
Measured: April 2016 - December 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study startApr 2016
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postthrombotic SyndromeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ostfold Hospital Trust, St. Olavs Hospital, Vestre Viken Hospital Trust, Sahlgrenska University Hospital, Kristianstad University, Jewish General Hospital, McMaster University
- Responsible party
- Principal investigator, Hilde Skuterud Wik, Oslo University Hospital
- Investigators
- Hilde S Wik, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050138
- Sponsor's protocol ID
- 2014/151
- Acronym
- DABI-PTS
- Status last verified
- Apr 2019
- First submitted
- 8 Feb 2017
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26422814Schulman 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.
PubMed 19966341Schulman 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.
PubMed 24344086
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03050138
- Acronym / sponsor ID
- DABI-PTS / 2014/151
- Conditions
- Postthrombotic Syndrome
- Keywords
- Postthrombotic Syndrome, Venous Thrombosis, Quality of Life, Hemorrhage, Recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Ostfold Hospital Trust, St. Olavs Hospital, Vestre Viken Hospital Trust, Sahlgrenska University Hospital, Kristianstad University, Jewish General Hospital, McMaster University
- Study start
- Apr 2016 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Prevalence of recurrent venous thromboembolism (VTE) after the discontinuation of study treatment.
- Prevalence of PTS determined by the standard Villalta score.
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients with DVT (±PE) treated in the RE-COVER studies.
- Signed written informed consent.
Key exclusion criteria (2 listed)
- Patients who refuse to participate
- Deceased patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Recurrent venous thromboembolism
Time frame: April 2016 - December 2017
Post-thrombotic syndrome (PTS) determined by the standard Villalta score
Time frame: April 2016 - December 2017
Generic health related Quality of Life (HRQoL)
Time frame: April 2016 - December 2017
Disease specific health related Quality of Life (HRQoL)
Time frame: April 2016 - December 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Background: PubMed 26422814Utne 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.
- Background: PubMed 19966341Schulman 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.
- Background: PubMed 24344086Schulman 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.
- Individual participant dataSharing planned: No
Related trials for Postthrombotic Syndrome
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Recruiting
PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis
Deep Vein Thrombosis
Not yet recruitingObservational study
Vflower Stent System for Iliofemoral Vein Stenosis and Occlusion: A Multicenter Real-World Study
Iliofemoral Vein Stenosis, Iliofemoral Vein Occlusion
Recruiting
Outcomes of Iliac Vein Stenting With Dedicated Venous Stents in Treatment of Chronic Post-thrombotic Venous Ulcers
Vascular, DVT - Deep Vein Thrombosis
RecruitingPhase 3
Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial)
Venous Thromboembolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilde S Wik, MD, PhD principal investigator
Oslo University Hospital
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postthrombotic Syndrome, run by Oslo University Hospital at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-thrombotic syndrome (PTS) (time frame: April 2016 - December 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03050138, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.