Application of "I-Anticoagulation"in Patients With Atrial Fibrillation

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation; Anticoagulants
• Intervention / Treatment: Other: Use of "I-Anticoagulation" to make the decision and manage patients

• Study Type: Interventional
• Enrollment (Estimated): 440
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SDM group; 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; 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.
No Intervention: Control group; AF patients in the control group will receive standard care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

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: IIT-2023-0207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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