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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation; Anticoagulant Therapy

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.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Shujuan Zhao; Phone Number: 0086-13837101436; Email: 49800425@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

AF patients receiving anticoagulants (outpatient or inpatient) in China

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Detailed data on management of NOAC-related adverse events will be collected.	3 years

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital
• Investigators: Principal Investigator: Shujuan Zhao, Henan Provincial People's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: April 23, 2022
• First Submitted That Met QC Criteria: May 1, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 20220406

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No