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Completed

NCT Number: NCT01029743

Xarelto Regulatory Post-Marketing Surveillance

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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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

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

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

Drug

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

Primary outcomes

  1. Adverse event collection

    Time frame: From the start of signed consent to 4 weeks after discharge

Secondary outcomes

  1. Duration of treatment

    Time frame: Whole treatment period

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

Xarelto® Regulatory Post-Marketing Surveillance

Important dates

Study start
2009
Primary completion
2015
Study completion
2016
First posted
Dec 10, 2009
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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