ReAl-life multIceNter Outcomes Registry for Better antithrOmbotic Strategies in Patients With AF (RAINBOW-AF)

NCT05361889 | Unknown

• 1 other identifier: 20220406
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Anticoagulation therapy is the most important part of the treatment strategy for atrial fibrillation. Previous studies have confirmed that both warfarin and new oral anticoagulants can effectively prevent stroke in patients with atrial fibrillation. However, the current situation of anticoagulation in atrial fibrillation is not optimistic. This project aims to explore the prevalence of inappropriate doses of anticoagulants in my country. , and the influencing factors related to such doses. By analyzing the status quo, characteristics and influencing factors, suggestions and management plans to promote rational use are put forward to provide certain guidance and help for anticoagulation therapy in patients with atrial fibrillation.

Conditions

Atrial Fibrillation; Anticoagulant Therapy

Outcome Measures

Primary Outcomes (3)

• Prevalence of potentially inappropriate NOAC prescriptions

  We will adopt an adaptive design to involve for summary of products characteristics, and perform appropriateness assessments of prevalent NOAC strategies based on indications, NOAC selection, or dosages according to reference materials from approved NMPA labeling recommendations for each agent and 2021 European Heart Rhythm Association (EHRA) Practical Guide on the Use of NOACs in AF Patients.

  3 years

• Patient profiles with NOAC prescriptions

  Identify the characteristics of participants who were given appropriate NOAC prescriptions and those who did not from various perspectives: demographics, clinical, medical management, prescription information, therapy, regional differences, types of treating physicians, and NOACs availability.

  3 years

• Number of major bleeding events

  Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.

  3 years

Secondary Outcomes (1)

• Adverse events

  3 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

AF patients receiving anticoagulants (outpatient or inpatient) in China

You may qualify if:

• Patients with incident (initial diagnosis) AF (Atrial Fibrillation) with electrocardiographic documentation or patients with prevalent (existing diagnosis) AF who had initiation or transition to a NOAC
• Anticipated ability to adhere to local regularly scheduled follow-up visits

You may not qualify if:

• Atrial flutter only
• Anticipated life expectancy less than 6 months
• Atrial fibrillation caused by reversible factors, such as hyperthyroidism, acute myocardial infarction, acute pulmonary embolism, etc.
• Active bleeding, such as intracranial hemorrhage, gastrointestinal bleeding, etc.
• Patients with deep vein thrombosis, pulmonary embolism, artificial hip/knee replacement and other anticoagulation indications
• Participation in a randomized trial of anticoagulation for AF at the time of enrollment

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Related Publications (1)

• Zhao SJ, Chen BY, Hong XJ, Liu YP, Cai HX, Du S, Gu ZC, Ma PZ. Prevalence, risk factors, and prediction of inappropriate use of non-vitamin K antagonist oral anticoagulants in elderly Chinese patients with atrial fibrillation: A study protocol. Front Cardiovasc Med. 2022 Aug 24;9:951695. doi: 10.3389/fcvm.2022.951695. eCollection 2022.

  PMID: 36093129 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shujuan Zhao

  Henan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shujuan Zhao

CONTACT

0086-13837101436; 49800425@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: May 5, 2022
• Study Start: September 1, 2022
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 19, 2022

Record last verified: 2022-05