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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 440
- 主要终点
- Any bleeding events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Any bleeding events
时间窗: 1st, 3rd, 6th, 9th, and 12th months
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.
次要结局
- The percentage of time in the target INR range for patients using warfarin(1st, 3rd, 6th, 9th, and 12th months)
- The accordance of stroke prophylaxis for AF according to current guidelines(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)
- Satisfaction of AF patients receiving anticoagulation therapy(1st, 3rd, 6th, 9th, and 12th months)