Xarelto [SPAF] Post-marketing Surveillance in Japan

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01582737
• Collaborator: Janssen Research & Development, LLC (Industry)
• Enrollment: 11,310
• Location: 1
• Actual Duration (Months): 91.6
• Patients Per Site Per Month: 123.5

Study Details

Study Description

Brief Summary

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.

The objective of this study is to assess safety and effectiveness of Xarelto using in real clinical practice.

A total of 10,000 patients are to be enrolled and assessed in 2 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.

Condition or Disease	Intervention/Treatment	Phase
Brain Ischemia	Drug: Rivaroxaban(Xarelto, BAY59-7939)

Study Design

• Study Type: Observational
• Actual Enrollment: 11310 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Special Drug Use Investigation of Xarelto [SPAF]
• Actual Study Start Date: May 30, 2012
• Actual Primary Completion Date: Mar 31, 2019
• Actual Study Completion Date: Jan 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Patients treated with Xarelto for the purpose of prevention of ischemic stroke and systemic embolism	Drug: Rivaroxaban(Xarelto, BAY59-7939); Patients treated with Xarelto under practical manner

Outcome Measures

Primary Outcome Measures

1. Incidence of ADRs and serious AEs (especially for hemorrhagic events, and liver disfunction with increase of liver-function-relating enzymes including bilirubin) [Up to 2 years]

2. Incidence of events of stroke [Up to 5 years]

3. Incidence of events of non-central nervous system embolism [Up to 5 years]

Secondary Outcome Measures

1. Determination of patient's demography to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey [Baseline]

2. Determination of patient's medical history to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey [Baseline]

3. Determination of patient's background to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey [Baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• PPatients with non-valvular atrial fibrillation (NVAF) for whom the decision to be treated with Xarelto was made

• Patients without experience of using Xarelto prior to the study

Exclusion Criteria:

• Patients who are contraindicated based on the product label

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Multiple Locations		Japan

Sponsors and Collaborators

• Bayer
• Janssen Research & Development, LLC

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here to find results for studies related to Bayer products

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01582737
• Other Study ID Numbers: 15798; XAR-SPAF
• First Posted: Apr 23, 2012
• Last Update Posted: Dec 30, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bayer: Xarelto; SPAF
• Additional relevant MeSH terms: Brain Ischemia; Ischemia; Rivaroxaban

Study Results

No Results Posted as of Dec 30, 2020