Atrial FibrillationNCT05361889
ReAl-life multIceNter Outcomes Registry for Better antithrOmbotic Strategies in Patients With AF (RAINBOW-AF)
An observational study of Atrial Fibrillation and Anticoagulant Therapy, run by Henan Provincial People's Hospital.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Anticoagulant Therapy
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: AF patients receiving anticoagulants (outpatient or inpatient) in China
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 years
Number of major bleeding events
Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.
Measured: 3 years
Secondary outcomes (1)
Adverse events
Detailed data on management of NOAC-related adverse events will be collected.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study startSep 2022 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shujuan Zhao, Principal investigator, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361889
- Sponsor's protocol ID
- 20220406
- Status last verified
- May 2022
- First submitted
- 23 Apr 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36093129
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReAl-life multIceNter Outcomes Registry for Better antithrOmbotic Strategies in Patients With AF (RAINBOW-AF)
- ClinicalTrials.gov ID
- NCT05361889
- Acronym / sponsor ID
- 20220406
- Conditions
- Atrial Fibrillation, Anticoagulant Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- AF patients receiving anticoagulants (outpatient or inpatient) in China
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of potentially inappropriate NOAC prescriptions
Time frame: 3 years
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.
Patient profiles with NOAC prescriptions
Time frame: 3 years
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.
Number of major bleeding events
Time frame: 3 years
Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.
1 secondary outcome
Adverse events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Derived from this study: PubMed 36093129Zhao 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.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shujuan Zhao principal investigator
Henan Provincial People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Anticoagulant Therapy, run by Henan Provincial People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shujuan Zhao (0086-13837101436, 49800425@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of potentially inappropriate NOAC prescriptions (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05361889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.