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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02268630
Other study ID # LOVE1213
Secondary ID
Status Recruiting
Phase N/A
First received August 6, 2014
Last updated February 15, 2017
Start date January 2014
Est. completion date October 2023

Study information

Verified date February 2017
Source Ostfold Hospital Trust
Contact Kristin K Utne, MD
Phone 004790417184
Email kristin.utne@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 460
Est. completion date October 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Locations

Country Name City State
Norway Ostfold Hospital Trust Fredrikstad Ostfold
Norway Akershus University Hospital Lørenskog Akershus
Norway Ullevål University Hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Ostfold Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
5 years
Secondary Bleeding Rate of bleeding during treatment with anticoagulation 9 years
Secondary Recurrence rate Recurrence rate during treatment and after discontinuation of anticoagulation. 9 years
Secondary Mortality rate Mortality rate following deep vein thrombosis and /or pulmonary embolism. 9 years
Secondary Severity of pulmonary embolism Severity of PE based on CT (Fredrikstad score) and troponin level. 9 years
Secondary Incidence of cancer Incidence of cancer after diagnosis of venous tromboembolism in screened and unscreened patients 9 years
Secondary Compliance in the use of Elastic compression stockings Compliance in the use of Elastic compression stockings 9 years
Secondary Risk factors Risk factors for venous thromboembolism 9 years
Secondary Resource utilization Resource utilization (number of contacts with health care providers, INR tests during anticoagulation) 9 years
Secondary Post thrombotic syndrome according to CEAP PTS according to CEAP score 9 years
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