Eliquis (VTE Treatment and Prevention of Recurrent VTE) rPMS

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546817
• Other study ID #: CV185-440
• Status: Completed
• Phase: N/A
• First received: September 7, 2015
• Last updated: October 27, 2017
• Start date: November 30, 2015
• Est. completion date: September 29, 2017

Study information

• Verified date: October 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 29, 2017
• Est. primary completion date: September 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Korea, Republic of	Local Institution	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Eliquis in Korean VTE patients based on incidence of adverse events (AEs), serious adverse events (SAEs)		Approximately 2 years
Primary	Patient characteristics that are associated with bleeding among patients taking Eliquis	Patient Characteristics: Age, sex, weight, height, baseline blood pressure, baseline serum creatinine, baseline creatinine clearance, and device insertion history	Approximately 2 years
Secondary	Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE	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	Approximately 2 years
Secondary	Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE	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	Approximately 2 years

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form