Xarelto Regulatory Post-Marketing Surveillance

Venous Thromboembolism Clinical Trial

Official title:

Xarelto® Regulatory Post-Marketing Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029743
• Other study ID #: 14793
• Secondary ID: XA0910KR
• Status: Completed
• Phase: N/A
• First received: December 9, 2009
• Last updated: January 19, 2017
• Start date: December 2009
• Est. completion date: January 2016

Study information

• Verified date: January 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is to identify the following problems and questions with respect to the safety and effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of venous thromboembolism (VTE) in a large sample of patients who undergo elective total hip replacement (THR) or total knee replacement (TKR) in the real-life conditions in its registered indication(s) as required by Korean Food and Drug Administration (KFDA).

1. Known and unknown adverse reactions, especially serious adverse reactions

2. Incidence of adverse reactions under the routine drug use

3. Factors that may affect the safety of the drug

4. Factors that may affect the effectiveness of the drug

5. Other safety information related to overuse, drug interaction and laboratory abnormalities

6. Other adverse reactions

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3388
• Est. completion date: January 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female and male patients >/= 18 years of age who will undergo elective total hip replacement or total knee replacement and receive Xarelto or other pharmacologic standard of care Venous Thromboembolism (VTE) prophylaxis, and who consent to participate in the study

Exclusion Criteria:

• Patients with hypersensitivity to any pharmacologic VTE prophylaxis treatment

• Patients with clinically significant active bleeding (e.g., intracranial bleeding, gastrointestinal bleeding)

• Patients with significant hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk

• Pregnant or lactating women

• Patients with hereditary problems of lactose or galactose intolerance (e.g., the Lapp lactase deficiency or glucose-galactose malabsorption)

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
Daily dose, a treatment duration of 5 weeks for patients undergoing major hip surgery and a treatment duration of 2 weeks for patients undergoing major knee surgery are recommended
• Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.)
Daily dose, dosage frequency and duration will be decided by physicians

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event collection		From the start of signed consent to 4 weeks after discharge
Secondary	Duration of treatment		Whole treatment period

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