Clinical trial NCT02546817: Eliquis (VTE Treatment and Prevention of Recurrent VTE) rPMS
Official title: Eliquis (Apixaban) Regulatory Postmarketing Surveillance In Real World Practice (rPMS) For Venous Thromboembolism (VTE) Treatment And Prevention Of Recurrent VTE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Treatment
Tx
Prevent
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-09-11
Enrollment: 29
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety of Eliquis in Korean VTE patients based on incidence of adverse events (AEs), serious adverse events (SAEs)
timeFrame: Approximately 2 years
measure: Patient characteristics that are associated with bleeding among patients taking Eliquis
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE
timeFrame: Approximately 2 years
measure: Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References: