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Completed

NCT Number: NCT02546817

Eliquis (VTE Treatment and Prevention of Recurrent VTE) rPMS

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • Recent gastrointestinal ulceration history
  • Recent intracranial or intracerebral haemorrhage history
  • Intraspinal or intracerebral vascular abnormalities
  • Recent brain, spinal or ophthalmic surgery history
  • Recent brain or spinal injury
  • Known or suspected oesophageal varices
  • Arteriovenous malformations
  • Vascular aneurysms
  • 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

Treatment and study plan

Primary outcomes

  1. Safety of Eliquis in Korean VTE patients based on incidence of adverse events (AEs), serious adverse events (SAEs)

    Time frame: Approximately 2 years

  2. Patient characteristics that are associated with bleeding among patients taking Eliquis

    Time frame: Approximately 2 years

    Patient Characteristics: Age, sex, weight, height, baseline blood pressure, baseline serum creatinine, baseline creatinine clearance, and device insertion history

Secondary outcomes

  1. Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE

    Time frame: 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

  2. Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE

    Time frame: Approximately 2 years

    For VTE treatment: The proportion of patients with recurrent VTE at 24 weeks will be calculated. The 95% confidence intervals 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 95% confidence intervals will be estimated

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Eliquis (Apixaban) Regulatory Postmarketing Surveillance In Real World Practice (rPMS) For Venous Thromboembolism (VTE) Treatment And Prevention Of Recurrent VTE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 11, 2015
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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