Xarelto Regulatory Post-Marketing Surveillance

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

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism
• Intervention / Treatment: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.)

• Study Type: Observational
• Enrollment (Actual): 3388

Contacts and Locations

Study Locations

• Korea, Republic of
  • Many Locations, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who will be treated with rivaroxaban or other pharmacologic agents (e.g. LMWH/VKA/Fondaparinux) to prevent VTE after elective total hip replacement or total knee replacement

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	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
Group 2	Drug: Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.); Daily dose, dosage frequency and duration will be decided by physicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse event collection	From the start of signed consent to 4 weeks after discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of treatment	Whole treatment period

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: December 9, 2009
• First Submitted That Met QC Criteria: December 9, 2009
• First Posted (ESTIMATE): December 10, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 23, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: TKR (Total Knee Replacement); THR (Total Hip Replacement); VTE (Venous Thromboembolism); LMWH (Low Molecular Weight Heparin); VKA (Vitamin K antagonist)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Aspirin; Rivaroxaban; Fondaparinux; PENTA
• Other Study ID Numbers: 14793; XA0910KR (OTHER: company internal)