Eliquis (VTE Treatment and Prevention of Recurrent VTE) rPMS

NCT02546817 | Completed

• 1 other identifier: CV185-440
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolism

Keywords

Treatment; Tx; Prevent

Outcome Measures

Primary Outcomes (2)

• 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

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

  Approximately 2 years

Secondary Outcomes (2)

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

  Approximately 2 years

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

  Approximately 2 years

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Seoul, South Korea

Location

Related Links

• Investigator Inquiry Form

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: September 11, 2015
• Study Start: November 30, 2015
• Primary Completion: September 29, 2017
• Study Completion: September 29, 2017
• Last Updated: October 31, 2017

Record last verified: 2017-10

Locations

KR (1)