Clinical trial NCT06137794: Application of "I-Anticoagulation"in Patients With Atrial Fibrillation
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Anticoagulants
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Any bleeding events
timeFrame: 1st, 3rd, 6th, 9th, and 12th months
Secondary outcomes:
measure: The accordance of stroke prophylaxis for AF according to current guidelines
timeFrame: 1st, 3rd, 6th, 9th, and 12th months
measure: The percentage of time in the target INR range for patients using warfarin
timeFrame: 1st, 3rd, 6th, 9th, and 12th months
measure: The occurrences of major bleeding and thrombosis events
timeFrame: 1st, 3rd, 6th, 9th, and 12th months
measure: OAC knowledge of AF patients receiving anticoagulation therapy
timeFrame: 1st, 3rd, 6th, 9th, and 12th months
measure: OAC adherence of AF patients receiving anticoagulation therapy
timeFrame: 1st, 3rd, 6th, 9th, and 12th months
measure: Satisfaction of AF patients receiving anticoagulation therapy
timeFrame: 1st, 3rd, 6th, 9th, and 12th months
Other outcomes:
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