Application of I-Anticoagulationin Patients With Atrial Fibrillation

Study Overview
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Brief Summary
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The goal of this prospective, multicenter, cluster randomized controlled trial is to assess the effectiveness of a shared decision-making tool, I-Anticoagulation, for anticoagulation management in AF patients. The main questions it aims to answer are: whether I-Anticoagulation could help improve the rational use of anticoagulants in AF patients; whether I-Anticoagulation could help increase the adherence and satisfaction of AF patients receiving anticoagulants. The anticoagulation therapy of AF patients will be determined by clinicians with the use of I-Anticoagulation, and AF patients will be managed using I-Anticoagulation during their anticoagulation therapy. Researchers will compare the outcomes with the control group, in which patients with AF will receive standard care.

Official Title
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Application of the Anticoagulation Decision-making and Management Model Based on the I-Anticoagulation Tool in Patients With Atrial Fibrillation: A Prospective, Multicenter, Cluster Randomized Controlled Study

Conditions
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Atrial Fibrillation, Anticoagulants

Intervention / Treatment
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* Other: Use of I-Anticoagulation to make the decision and manage patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who are 18 years or older and have received a new diagnosis of paroxysmal, persistent, or permanent AF confirmed by electrocardiogram (ECG) or 24-hour Holter monitors must be willing to participate in the study and sign the informed consent Exclusion Criteria: those who are pregnant those whohave experienced therapeutic or subtherapeutic bleeding complications in the last 6 months those who have severe renal insufficiency (creatinine clearance rate, CrCl ≤ 20 ml/min) those who have severe hepatic insufficiency (Child-Pugh ≥ 10 points) those who have severe heart failure (cardiac function New York Heart Association, NYHA grade IV and above) those who have severe infection and respiratory failure those who are unable to comply with the study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SDM group<br>The anticoagulation therapy of AF patients will be determined by clinicians with the use of I-Anticoagulation, and AF patients will be managed using I-Anticoagulation during their anticoagulation therapy. | Other: Use of I-Anticoagulation to make the decision and manage patients<br>* I-Anticoagulation will offer a flexible and efficient communication platform for healthcare professionals and AF patients. The tool is composed of two modules: an anticoagulation decision support system and a full-process patient management system.<br>|
| No Intervention: Control group<br>AF patients in the control group will receive standard care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any bleeding events | Any bleeding events, including both major and minor bleeding events. Major bleeding events include fatal haemorrhage, life-threatening bleeding, and severe bleeding requiring treatment or assessment. Severe bleeding can manifest as gastric intestinal haemorrhage, joint haematoma, retroperitoneal haemorrhage, fundus haemorrhage, urine, haemoptysis, or require blood transfusion of at least two units. Minor bleeding events, such as mild nasal hemorrhage, endoscopic haematuria, skin stasis, or mild hemorrhoids, do not lead to serious consequences. | 1st, 3rd, 6th, 9th, and 12th months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accordance of stroke prophylaxis for AF according to current guidelines | The accordance of stroke prophylaxis for AF according to current guidelines, i.e., whether the prescriptions meet the recommendations on clinical guidelines, including the choice, usage and dosage of oral anticoagulants. | 1st, 3rd, 6th, 9th, and 12th months | 
| The percentage of time in the target INR range for patients using warfarin | The percentage of time in which the INR remains in the 1.8 to 3.0 target range across time for patients using warfarin. | 1st, 3rd, 6th, 9th, and 12th months | 
| The occurrences of major bleeding and thrombosis events | The occurrences of major bleeding and thrombosis events. Major bleeding events include fatal haemorrhage, life-threatening bleeding, and severe bleeding requiring treatment or assessment. Severe bleeding can manifest as gastric intestinal haemorrhage, joint haematoma, retroperitoneal haemorrhage, fundus haemorrhage, urine, haemoptysis, or require blood transfusion of at least two units. Thrombosis events, including ischaemic stroke, systemic embolism, and transient ischaemic attacks, will be confirmed by imaging methods such as ultrasound, CT, or MRI. | 1st, 3rd, 6th, 9th, and 12th months | 
| OAC knowledge of AF patients receiving anticoagulation therapy | The AKT comprises 28 items assessing general anticoagulation knowledge for all available OAC and a specific section for VKAs therapy. | 1st, 3rd, 6th, 9th, and 12th months | 
| OAC adherence of AF patients receiving anticoagulation therapy | The MARS-5 assesses common patterns of nonadherent behavior. | 1st, 3rd, 6th, 9th, and 12th months | 
| Satisfaction of AF patients receiving anticoagulation therapy | The ACTS evaluates the burdens and benefits of anticoagulation treatment and its overall impact. | 1st, 3rd, 6th, 9th, and 12th months |