NCT02155491

Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10,679 (actual)
• Sponsor: Thrombosis Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Thromboembolism
• Deep Vein Thrombosis
• Pulmonary Embolism

Timeline

• Start date: 2014-07-07
• Primary completion: 2020-01-04
• Completion: 2020-09-30
• First posted: 2014-06-04
• Last updated: 2021-05-05

Locations

1 site across 1 country: United States