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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Atrial Fibrillation; Anticoagulants

Treatments: Other: Use of "I-Anticoagulation" to make the decision and manage patients

Study type: Interventional

Funder types: Other

Identifiers

NCT06137794

IIT-2023-0207

Details and patient eligibility

About

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.

Enrollment: 440 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 2 patient groups

SDM group

Experimental group

Description:

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.

Treatment:

Other: Use of "I-Anticoagulation" to make the decision and manage patients

Control group

No Intervention group

Description:

AF patients in the control group will receive standard care.