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

NCT ID: NCT05361889

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2025-08-31

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.

Detailed Description

The project is carried out in 30 research centers across the country, and the research object is the prescription/medical order data of real-world atrial fibrillation patients (outpatient and inpatient), including clinical diagnosis, drug use, outpatient and emergency and inpatient records, medical records, as well as laboratory tests, Demographic and other aspects of information, a total of 5000 patients were included, and it is expected to be completed within 3 years. The analysis indicators include patient population distribution, comorbid diseases, concomitant drugs, creatinine clearance rate, proportion of various drugs used, CHA2DS2-VASc score and embolism risk, HAS-BLED score, antithrombotic therapy, etc., to evaluate the influencing factors of inappropriate anticoagulation dose, and to explore the macro trend of anticoagulation therapy.

Conditions

Atrial Fibrillation; Anticoagulant Therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shujuan Zhao

Role: PRINCIPAL_INVESTIGATOR

Henan Provincial People's Hospital

Central Contacts

Shujuan Zhao

Role: CONTACT

49800425@qq.com

0086-13837101436

References

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.

Reference Type: DERIVED

PMID: 36093129 (View on PubMed)

Other Identifiers

20220406

Identifier Type: -

Identifier Source: org_study_id