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

RenJi Hospital440 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

440

Conditions

Atrial Fibrillation Anticoagulants

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.