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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06137794
Other study ID # IIT-2023-0207
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 15, 2023
Est. completion date June 30, 2025

Study information

Verified date November 2023
Source RenJi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 440
Est. completion date June 30, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary OAC adherence of AF patients receiving anticoagulation therapy The MARS-5 assesses common patterns of nonadherent behavior. 1st, 3rd, 6th, 9th, and 12th months
Secondary 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
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