Eliquis (VTE Treatment and Prevention of Recurrent VTE) rPMS

Completed

• Conditions: Venous Thromboembolism

• Registration Number: NCT02546817
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-11
• Study Start: 2015-11-30
• Primary Completion: 2017-09-29
• Study Completion: 2017-09-29
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Safety of Eliquis in Korean VTE patients based on incidence of adverse events (AEs), serious adverse events (SAEs)	Approximately 2 years

Secondary Outcome Measures

Name	Time	Method
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 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

Trial Locations

Locations (1)

Local Institution; 🇰🇷 Seoul, Korea, Republic of