Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology, Cardiology, Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2014 |
| End Date: | December 2018 |
| Contact: | Glorya Kayani |
| Email: | gkayani@tri-london.ac.uk |
Global Anticoagulant Registry in the Field Observing Treatment and Outcomes in Patients With Treated Acute Venous Thromboembolic Events in the Real World
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
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
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.
- 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.
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)
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