Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events

Study Overview
=================
Brief Summary
-----------------
The protocol is a large registry to describe acute, sub-acute and extended duration of anticoagulation management, clinical and economic duration of anticoagulation management, clinical and economic outcomes in patients with treated acute VTE (DVT and PE) in the real-world setting. Main objectives are to clarify the: treatment related details for acute VTE (either conventional anticoagulation therapy, treatment with a direct oral anti-coagulant or other modalities of treatment) Rate of early and late symptomatic VTE recurrence Rate and nature of complications of VTE including post thrombotic syndrome and chronic thromboembolic pulmonary hypertension Rate of bleeding complications Rate of all-cause mortality at six months

Detailed Description
-----------------
Other objectives are to clarify the additional outcomes of: Stroke (Measured by number of incidences) Transient Ischemic Attack (TIA) (Measured by number on incidences) ST Elevated Myocardial Infarction (STEMI) (Measured by number of incidences) Non-ST Elevated Myocardial Infraction (NSTEMI) (Measured by number of incidences) Unstable Angina (Measured by number of incidences) Quality of life and patient reported outcomes and costs associated with the management of VTE.

Official Title
-----------------
Global Anticoagulant Registry in the Field Observing Treatment and Outcomes in Patients With Treated Acute Venous Thromboembolic Events in the Real World

Conditions
-----------------
Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Age 18 years and over Treated first time or recurrent DVT (lower or upper extremity), PE alone or overlapping DVT and PE confirmed by appropriate diagnostic methods (patients must be assessed for eligibility within 30 days of diagnosis) Patients included with recurrent VTE must have completed treatment for the previous VTE episode Exclusion Criteria: Patients for whom long-term follow-up is not envisaged within the enrolling hospital or the associated primary care physician Patients participating in an interventional study that dictates treatments, visit frequency, or diagnostic procedures Patients with only superficial vein thrombosis (SVT)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective cohort 1<br>In order to observe temporal trends in management of VTE a first cohort of 5000 consecutive unselected patients treated for acute VTE will be recruited. This cohort will take approximately 9 months to recruit. Potential patients must be assessed for eligibility within 30 days of their acute VTE diagnosis. They will be followed prospectively for 36 months. | |
| Prospective cohort 2<br>In order to observe temporal trends in management of VTE a second cohort of 5000 consecutive unselected patients treated for acute VTE will be recruited. Recruitment into the second cohort will commence when recruitment is completed in the first cohort. This cohort will take approximately 9 months to recruit. Potential patients must be assessed for eligibility within 30 days of their acute VTE diagnosis. They will be followed prospectively for 36 months. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE) | Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE) | 36 months | 
| Bleeding events | Frequency, location, severity (classified as major or non-major) | 36 months | 
| Hospitalization | Measured by number of occurrences. | 36 months | 
| Post Thrombotic Syndrome | Measured by number of occurrences and severity. | 36 months | 
| Chronic thromboembolic pulmonary hypertension | Measured by number of occurrences and severity. | 36 months | 
| IVC filter placement | Measured by number of occurrences. | 36 months | 
| Other urgent interventions for VTE | Measured by number of occurrences. | 36 months | 
| Anticoagulation therapy persistence | Estimation of Anticoagulation therapy will be compared to actual total time Anticoagulation therapy was used by patients. | 36 months | 
| All cause of mortality | Causes of death: PE, stroke, cardiac, cancer-related, other... | 36 months | 
| International Normalized Ratio (INR) Values in Patients treated with Vitamin K Antagonists | Will be assessed by frequency of INR monitoring, and number of INR readings taken before patient achieved optimum range. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke | Ischemic stroke, hemorrhagic stroke | 36 months | 
| Trans Ischemic Attack (TIA) | Measured by number of occurrences. | 36 months | 
| Myocardial Infarction | Measured by number of occurrences of both ST-Elevated Myocardial Infarction and Non-ST Elevated Myocardial Infarction (STEMI/NSTEMI). | 36 months | 
| Unstable angina | Measured by number of occurrences. | 36 months | 
| Quality of life and patient treatment satisfaction over a three year period | Measured by Questionnaire. | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
venous, thromboembolism, embolism, DVT, Pulmonary Embolism, thrombosis