Xarelto Regulatory Post-Marketing Surveillance

NCT01029743 | Completed

• 2 other identifiers: 14793XA0910KR
• Study Type: observational
• Target: 3,388
• Locations: 1 country
• Sites: 1

Brief 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. 1.Known and unknown adverse reactions, especially serious adverse reactions
2. 2.Incidence of adverse reactions under the routine drug use
3. 3.Factors that may affect the safety of the drug
4. 4.Factors that may affect the effectiveness of the drug
5. 5.Other safety information related to overuse, drug interaction and laboratory abnormalities
6. 6.Other adverse reactions

Conditions

Venous Thromboembolism

Keywords

TKR (Total Knee Replacement); THR (Total Hip Replacement); VTE (Venous Thromboembolism); LMWH (Low Molecular Weight Heparin); VKA (Vitamin K antagonist)

Outcome Measures

Primary Outcomes (1)

• Adverse event collection

  From the start of signed consent to 4 weeks after discharge

Secondary Outcomes (1)

• Duration of treatment

  Whole treatment period

Study Arms (2)

Group 1

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Group 2

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

Interventions

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

Group 1

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

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

Group 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

Unknown Facility

Many Locations, South Korea

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Rivaroxaban; Aspirin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 10, 2009
• Study Start: December 1, 2009
• Primary Completion: March 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

KR (1)