Clinical trial NCT02155491: Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events
Official title: Global Anticoagulant Registry in the Field Observing Treatment and Outcomes in Patients With Treated Acute Venous Thromboembolic Events in the Real World
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary Embolism
Keywords: venous, thromboembolism, embolism, DVT, Pulmonary Embolism, thrombosis
Lead sponsor: Thrombosis Research Institute
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2014-06-04
Enrollment: 10679
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sites will be selected at random from a representative list reflecting treatment patterns in each country. Consecutive male and female VTE patients at the randomly selected sited will be included in the registry if they meet the eligibility criteria.

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.

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)

Primary outcomes:
measure: Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE)
timeFrame: 36 months
measure: Bleeding events
timeFrame: 36 months
measure: Hospitalization
timeFrame: 36 months
measure: Post Thrombotic Syndrome
timeFrame: 36 months
measure: Chronic thromboembolic pulmonary hypertension
timeFrame: 36 months
measure: IVC filter placement
timeFrame: 36 months
measure: Other urgent interventions for VTE
timeFrame: 36 months
measure: Anticoagulation therapy persistence
timeFrame: 36 months
measure: All cause of mortality
timeFrame: 36 months
measure: International Normalized Ratio (INR) Values in Patients treated with Vitamin K Antagonists
timeFrame: 36 months
Secondary outcomes:
measure: Stroke
timeFrame: 36 months
measure: Trans Ischemic Attack (TIA)
timeFrame: 36 months
measure: Myocardial Infarction
timeFrame: 36 months
measure: Unstable angina
timeFrame: 36 months
measure: Quality of life and patient treatment satisfaction over a three year period
timeFrame: 36 months
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Dr Terence Hart
state: Alabama
Study officials:
affiliation: Thrombosis Research Institute
name: Ajay K Kakkar, MD
role: STUDY_DIRECTOR
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