Xarelto Regulatory Post-Marketing Surveillance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3388 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2016-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

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

Group 2

Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.)

Intervention Type DRUG

Daily dose, dosage frequency and duration will be decided by physicians

Interventions

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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

Intervention Type DRUG

Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.)

Daily dose, dosage frequency and duration will be decided by physicians

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No