Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events (GARFIELD-VTE)

Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events (GARFIELD-VTE)

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.


Study Type: Observational [Patient Registry]
Estimated Enrollment: 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Global Anticoagulant Registry in the Field Observing Treatment and Outcomes in Patients With Treated Acute Venous Thromboembolic Events in the Real World
Actual Study Start Date: July 7, 2014
Estimated Primary Completion Date: January 4, 2020
Estimated Study Completion Date: January 4, 2020

Group/Cohort:
- Prospective cohort 1
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
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.

View full details