Long Term Outcomes of Venous Thromboembolism (LOVE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02268630|
Recruitment Status : Recruiting
First Posted : October 20, 2014
Last Update Posted : February 16, 2017
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.
|Condition or disease|
|Post Thrombotic Syndrome Chronic Thromboembolic Pulmonary Hypertension Venous Thrombosis|
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 Type :||Observational|
|Estimated Enrollment :||460 participants|
|Official Title:||Long Term Outcomes of Venous Thromboembolism -the LOVE Study-|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||October 2023|
Patients treated with Warfarin for VTE
Patients treated with Rivaroxaban for VTE
- 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.
- Bleeding [ Time Frame: 9 years ]Rate of bleeding during treatment with anticoagulation
- Recurrence rate [ Time Frame: 9 years ]Recurrence rate during treatment and after discontinuation of anticoagulation.
- Mortality rate [ Time Frame: 9 years ]Mortality rate following deep vein thrombosis and /or pulmonary embolism.
- Severity of pulmonary embolism [ Time Frame: 9 years ]Severity of PE based on CT (Fredrikstad score) and troponin level.
- Incidence of cancer [ Time Frame: 9 years ]Incidence of cancer after diagnosis of venous tromboembolism in screened and unscreened patients
- Compliance in the use of Elastic compression stockings [ Time Frame: 9 years ]Compliance in the use of Elastic compression stockings
- Risk factors [ Time Frame: 9 years ]Risk factors for venous thromboembolism
- Resource utilization [ Time Frame: 9 years ]Resource utilization (number of contacts with health care providers, INR tests during anticoagulation)
- Post thrombotic syndrome according to CEAP [ Time Frame: 9 years ]PTS according to CEAP score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268630
|Contact: Kristin K Utne, MDemail@example.com|
|Contact: Waleed Ghanima, PhDfirstname.lastname@example.org|
|Akershus University Hospital||Recruiting|
|Lørenskog, Akershus, Norway, 1478|
|Ostfold Hospital Trust||Recruiting|
|Fredrikstad, Ostfold, Norway, 1606|
|Principal Investigator: Kristin K Utne, MD|
|Ullevål University Hospital||Not yet recruiting|
|Oslo, Norway, 0450|
|Principal Investigator:||Kristin K Utne, MD||Ostfold Hospital Trust|
|Study Director:||Waleed Ghanima, PhD||Ostfold Hospital Trust|