Venous Thromboembolism
Conditions
Keywords
Treatment, Tx, Prevent
Brief summary
To assess the real-world safety/effectiveness of Eliquis in Korean venous thromboembolism (VTE) patients and patient characteristics that are associated with bleeding among patients taking Eliquis. To identify factors that might be associated with the safety and effectiveness profile in Korean VTE patients.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (≥19 years of age) patients who are initiating treatment with Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time in accordance with the Korean package insert will be enrolled in the study
Exclusion criteria
* Patients with prior treatment with Eliquis before enrollment in this study * Patients receiving Eliquis treatment for an indication not approved indication in Korea * Patients meeting any of the following criteria will not be included in the study: i) Hypersensitivity to the active substance or to any of the excipients ii) Clinically significant active bleeding iii) Hepatic disease associated with coagulopathy and clinically relevant bleeding risk iv) Patients with increased bleeding risk due to such as following diseases: 1. Recent gastrointestinal ulceration history 2. Recent intracranial or intracerebral haemorrhage history 3. Intraspinal or intracerebral vascular abnormalities 4. Recent brain, spinal or ophthalmic surgery history 5. Recent brain or spinal injury 6. Known or suspected oesophageal varices 7. Arteriovenous malformations 8. Vascular aneurysms 9. Patients with malignant neoplasms at high risk of bleeding * Concomitant treatment with any other anticoagulant agent: i) Unfractionated heparin (UFH) ii) Low molecular weight heparins (enoxaparin, dalteparin, etc) iii) Heparin derivatives (fondaparinux, etc) iv) oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc) except under the circumstances of switching therapy to or from apixaban or when UFH is given at doses necessary to maintain a patent central venous or arterial catheter * Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Eliquis in Korean VTE patients based on incidence of adverse events (AEs), serious adverse events (SAEs) | Approximately 2 years | — |
| Patient characteristics that are associated with bleeding among patients taking Eliquis | Approximately 2 years | Patient Characteristics: Age, sex, weight, height, baseline blood pressure, baseline serum creatinine, baseline creatinine clearance, and device insertion history |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE | Approximately 2 years | For VTE treatment: The proportion of patients with recurrent VTE at 24 weeks will be calculated. The incidence proportion will be estimated For prevention of recurrent VTE: The proportion of patients with recurrent VTE at 24 weeks, 52 weeks, and 104 weeks, will be calculated. The incidence proportion will be estimated |
Countries
South Korea
Outcome results
None listed