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

NCT06137794 | Unknown

• 1 other identifier: IIT-2023-0207
• Study Type: interventional
• Target: 440
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation; Anticoagulants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The accordance of stroke prophylaxis for AF according to current guidelines

  1st, 3rd, 6th, 9th, and 12th months

• The percentage of time in the target INR range for patients using warfarin

  1st, 3rd, 6th, 9th, and 12th months

• The occurrences of major bleeding and thrombosis events

  1st, 3rd, 6th, 9th, and 12th months

• OAC knowledge of AF patients receiving anticoagulation therapy

  1st, 3rd, 6th, 9th, and 12th months

• OAC adherence of AF patients receiving anticoagulation therapy

  1st, 3rd, 6th, 9th, and 12th months

Study Arms (2)

SDM group

EXPERIMENTAL

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

Control group

NO INTERVENTION

AF patients in the control group will receive standard care.

Interventions

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

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.

SDM group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: November 18, 2023
• Study Start: November 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share