Post Thrombotic SyndromeLOVENCT02268630
Long Term Outcomes of Venous Thromboembolism
An observational study of Post Thrombotic Syndrome and Chronic Thromboembolic Pulmonary Hypertension, run by Ostfold Hospital Trust at 3 sites in Norway.
Trial summary
This prospective observational follow-up study is designed to assess the long-term outcomes after Venous thromboembolism (VTE) and to assess the effect of the new oral anticoagulant (NOAC) rivaroxaban on the prevalence of post-thrombotic syndrome (PTS). The study will not be testing any formal hypothesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Thrombotic Syndrome, Chronic Thromboembolic Pulmonary Hypertension, Venous Thrombosis
- How many people
- 460 participants
- Where
- 3 sitesNorway
- Study dates
- Jan 2014to Oct 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with VTE in Østfold who fulfil study criteria will be invited to participate.
Who may be able to join
- Patients with objectively verified first time DVT diagnosed after 01.01.11 for study A, OR objectively verified DVT and/or PE dignosed after 01.04.14 for study B.
- 18 years of age
- Signed informed written consent
Who cannot join
- Patients who refuse to consent
- Patients who have been treated with other anticoagulants than thoose included in the study
- Patients who can not participate due to logistic reasons
Trial locations and contacts
3 sites in 1 country.
Norway3 sites, 3 recruiting
- Recruiting
Ostfold Hospital Trust
Fredrikstad, Østfold fylke, 1606
Kristin K Utne, MD
- Recruiting
Akershus University Hospital
Lørenskog, Akershus, 1478
- Not yet recruiting
Ullevål University Hospital
Oslo, Oslo, 0450
About this study
Official title: Long Term Outcomes of Venous Thromboembolism -the LOVE Study-
This prospective observational follow-up study is designed to assess the long-term outcomes after Venous thromboembolism (VTE) and to assess the effect of the new oral anticoagulant (NOAC) rivaroxaban on the prevalence of post-thrombotic syndrome (PTS).
The study will not be testing any formal hypothesis.
Read the detailed description
This prospective observational follow-up study is designed to assess the long-term outcomes after VTE and to assess the effect of NOAC (rivaroxaban) on the prevalence of PTS. All patients diagnosed and treated for VTE at SØF from 01.01.2011 will be invited to participate in this study. Newly diagnosed patients will be recruited and followed-up according to the study schedule which is based on state of the art international guidelines.
First follow-up will be performed at the end of treatment period, which is usually 3 or 6 months after an event of VTE, or at one year if patients will be put on permanent AC. Thereafter, patients will be followed-up annually for at least 5 years or up to the end of the study, i.e for 10 years.
The primary endpoints of the study are the development of PTS and CTEPH after VTE. There will be 3 visits: at 3 or 6 months depending on the duration of AC, at 2 and 5 years, in addition to a visit for TTE at 6 months. Remaining follow-ups will be performed by phone or by mail. All patients with PE will be examined by TTE 6 months after the diagnosis of PE. Those with signs of PAH will be referred for further work-up to establish the presence or absence of CTEPH at specialized centres. Patients with DVT will be evaluated for PTS at 2 and 5 years and for CTEPH if they develop dyspnoea. As for part b of the primary objective, the study will allow inclusion of patients with previous DVT diagnosed after 01.01.11.
- Conditions
- Post Thrombotic Syndrome, Chronic Thromboembolic Pulmonary Hypertension, Venous Thrombosis
- Keywords
- Post-thrombotic syndrome, Chronic thromboembolic pulmonary hypertension, Anticoagulation, Rivaroxaban
- Medical subject headings
- Postthrombotic Syndrome, Venous Thrombosis
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 |
|---|---|---|
| Group A | Patients treated with Warfarin for VTE | |
| Grup B | Patients treated with Rivaroxaban for VTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of post thrombotic syndrome and chronic thromboembolic pulmonary hypertension
Determine the prevalence of post thrombotic syndrome as defined by Villalta score at 2- and 5 years in an unselected population of venous thromboembolism patients.
Prevalence of chronic thromboembolic pulmonary hypertension in at 2- and 5 years in an unselected population of pulmonary embolism patients.
Measured: 5 years
Secondary outcomes (9)
Bleeding
Rate of bleeding during treatment with anticoagulation
Measured: 9 years
Recurrence rate
Recurrence rate during treatment and after discontinuation of anticoagulation.
Measured: 9 years
Mortality rate
Mortality rate following deep vein thrombosis and /or pulmonary embolism.
Measured: 9 years
Severity of pulmonary embolism
Severity of PE based on CT (Fredrikstad score) and troponin level.
Measured: 9 years
Incidence of cancer
Incidence of cancer after diagnosis of venous tromboembolism in screened and unscreened patients
Measured: 9 years
Compliance in the use of Elastic compression stockings
Compliance in the use of Elastic compression stockings
Measured: 9 years
Risk factors
Risk factors for venous thromboembolism
Measured: 9 years
Resource utilization
Resource utilization (number of contacts with health care providers, INR tests during anticoagulation)
Measured: 9 years
Post thrombotic syndrome according to CEAP
PTS according to CEAP score
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Thrombotic SyndromeStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin K Utne, MD, Principal investigator, Ostfold Hospital TrustWaleed Ghanima, PhD, Study director, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268630
- Sponsor's protocol ID
- LOVE1213
- Acronym
- LOVE
- Status last verified
- Feb 2017
- First submitted
- 6 Aug 2014
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcomes of Venous Thromboembolism -the LOVE Study-
- ClinicalTrials.gov ID
- NCT02268630
- Acronym / sponsor ID
- LOVE / LOVE1213
- Conditions
- Post Thrombotic Syndrome, Chronic Thromboembolic Pulmonary Hypertension, Venous Thrombosis
- Keywords
- Post-thrombotic syndrome, Chronic thromboembolic pulmonary hypertension, Anticoagulation, Rivaroxaban
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 20 Oct 2014 (estimated)
- 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.
This prospective observational follow-up study is designed to assess the long-term outcomes after Venous thromboembolism (VTE) and to assess the effect of the new oral anticoagulant (NOAC) rivaroxaban on the prevalence of post-thrombotic syndrome (PTS).
The study will not be testing any formal hypothesis.
Detailed description
This prospective observational follow-up study is designed to assess the long-term outcomes after VTE and to assess the effect of NOAC (rivaroxaban) on the prevalence of PTS. All patients diagnosed and treated for VTE at SØF from 01.01.2011 will be invited to participate in this study. Newly diagnosed patients will be recruited and followed-up according to the study schedule which is based on state of the art international guidelines.
First follow-up will be performed at the end of treatment period, which is usually 3 or 6 months after an event of VTE, or at one year if patients will be put on permanent AC. Thereafter, patients will be followed-up annually for at least 5 years or up to the end of the study, i.e for 10 years.
The primary endpoints of the study are the development of PTS and CTEPH after VTE. There will be 3 visits: at 3 or 6 months depending on the duration of AC, at 2 and 5 years, in addition to a visit for TTE at 6 months. Remaining follow-ups will be performed by phone or by mail. All patients with PE will be examined by TTE 6 months after the diagnosis of PE. Those with signs of PAH will be referred for further work-up to establish the presence or absence of CTEPH at specialized centres. Patients with DVT will be evaluated for PTS at 2 and 5 years and for CTEPH if they develop dyspnoea. As for part b of the primary objective, the study will allow inclusion of patients with previous DVT diagnosed after 01.01.11.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Patients treated with Warfarin for VTE |
| Grup B | – | –Patients treated with Rivaroxaban for VTE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with VTE in Østfold who fulfil study criteria will be invited to participate.
Key inclusion criteria (3 listed)
- Patients with objectively verified first time DVT diagnosed after 01.01.11 for study A, OR objectively verified DVT and/or PE dignosed after 01.04.14 for study B.
- Signed informed written consent
Key exclusion criteria (3 listed)
- Patients who refuse to consent
- Patients who have been treated with other anticoagulants than thoose included in the study
- Patients who can not participate due to logistic reasons
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
Prevalence of post thrombotic syndrome and chronic thromboembolic pulmonary hypertension
Time frame: 5 years
Determine the prevalence of post thrombotic syndrome as defined by Villalta score at 2- and 5 years in an unselected population of venous thromboembolism patients. Prevalence of chronic thromboembolic pulmonary hypertension in at 2- and 5 years in an unselected population of pulmonary embolism patients.
9 secondary outcomes
Bleeding
Time frame: 9 years
Recurrence rate
Time frame: 9 years
Mortality rate
Time frame: 9 years
Severity of pulmonary embolism
Time frame: 9 years
Incidence of cancer
Time frame: 9 years
Compliance in the use of Elastic compression stockings
Time frame: 9 years
Risk factors
Time frame: 9 years
Resource utilization
Time frame: 9 years
Post thrombotic syndrome according to CEAP
Time frame: 9 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
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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.
Kristin K Utne, MD principal investigator
Ostfold Hospital Trust
Waleed Ghanima, PhD study director
Ostfold Hospital Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Thrombotic Syndrome and Chronic Thromboembolic Pulmonary Hypertension, run by Ostfold Hospital Trust at 3 sites in Norway.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Feb 2017. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristin K Utne, MD (004790417184, kristin.utne@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of post thrombotic syndrome and chronic thromboembolic pulmonary hypertension (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2017; AzTrials last refreshed its copy on 6 Nov 2026.