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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05361889
• Other study ID #: 20220406
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: August 2025

Study information

• Verified date: May 2022
• Source: Henan Provincial People's Hospital
• Contact: Shujuan Zhao
• Phone: 0086-13837101436
• Email: 49800425[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulant Therapy
• Atrial Fibrillation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henan Provincial People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Number of major bleeding events	Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.	3 years
Secondary	Adverse events	Detailed data on management of NOAC-related adverse events will be collected.	3 years