Study of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With Rivaroxaban

NCT ID: NCT02975453

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1481 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-05

Study Completion Date

2020-08-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial fibrillation (NVAF) patients treated with rivaroxaban in Spain

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rivaroxaban

Non-valvular atrial fibrillation (NVAF) patients treated with rivaroxaban for at least 6 months prior to the study inclusion

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

As prescribed by the treating physician

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rivaroxaban (Xarelto, BAY59-7939)

As prescribed by the treating physician

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients aged 18 years or older.
* Patients with diagnosis of NVAF.
* Patients treated with rivaroxaban from at least six months prior to the study inclusion.
* Patients who have been given appropriate information about the study objectives and procedures and who have given their written informed consent.

Exclusion Criteria

* Patients participating in an investigational program with interventions outside of routine clinical practice.
* Patients who initiate treatment with rivaroxaban after the start of the study inclusion period.
* Prosthetic heart valves or the presence of any severe valvulopathies.
* Patients with severe cognitive impairment.
* Patients with chronic infections (HIV infection, hepatitis C virus, hepatitis B virus) or systemic autoimmune diseases.
* Patients with active cancer.
* Patients with liver insufficiency (eg. cirrhosis).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Multiple Locations, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Rivera-Caravaca JM, Anguita Sanchez M, Sanmartin Fernandez M, Rafols C, Baron-Esquivias G, Arribas Ynsaurriaga F, Freixa-Pamias R, Lekuona Goya I, Vazquez Rodriguez JM, Perez-Cabeza AI, Cosin-Sales J, Urena Montilla I, Alvarez-Vieitez Blanco A, Marin F. Adverse Clinical Outcomes and Associated Predictors in Rivaroxaban-Treated Atrial Fibrillation Patients With Renal Impairment. Am J Cardiol. 2023 Sep 15;203:122-127. doi: 10.1016/j.amjcard.2023.06.105. Epub 2023 Jul 22.

Reference Type BACKGROUND
PMID: 37487406 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18884

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.