DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA Region

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation

Intervention: Rivaroxaban (Xarelto, BAY59-7939) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Summary

This international study is a prospective noninterventional observational cohort study of patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in case of therapy was discontinued earlier than 12 months. Serious adverse events will be followed up adequately. Laboratory values (e. g., Hb, HCT, haemoccult) should be documented for each point in time they were measured.

Clinical Details

Official title: XANTUS-EL, Xarelto® on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Eastern EU, Middle East, Africa (EMEA) and Latin America (LATAM): A Noninterventional Study

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Adjudicated major bleeding events

Safety variables will be summarized using descriptivestatistics based on adverse events collection

Secondary outcome:

All cause mortality

Adjudicated symptomatic thromboembolic events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial

fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism, and who consent to participate in the study. Exclusion Criteria:

-

Locations and Contacts

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Many Locations, Algeria; Not yet recruiting

Many Locations, Argentina; Recruiting

Many Locations, Azerbaijan; Recruiting

Many Locations, Bahrain; Recruiting

Many Locations, Chile; Recruiting

Many Locations, Colombia; Recruiting

Many Locations, Ecuador; Not yet recruiting

Many Locations, Egypt; Recruiting

Many Locations, Georgia; Recruiting

ManyLocations, Jordan; Recruiting

Many Locations, Kazakhstan; Recruiting

Many Locations, Kazakhstan; Not yet recruiting

Many Locations, Kenya; Recruiting

Many Locations, Kuwait; Not yet recruiting

ManyLocations, Lebanon; Recruiting

Many Locations, Mexico; Recruiting

Many Locations, Morocco; Withdrawn

Many Locations, Peru; Not yet recruiting

Many Locations, Qatar; Not yet recruiting

Many Locations, Russian Federation; Recruiting

ManyLocations, Saudi Arabia; Recruiting

Many Locations, Ukraine; Withdrawn

Many Locations, United Arab Emirates; Recruiting

Many Locations, Uruguay; Recruiting

Many Locations, Venezuela; Recruiting

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: January 2013
Last updated: June 25, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017