跳至主要内容
临床试验/CTRI/2015/05/005782
CTRI/2015/05/005782已完成不适用

An International Multicenter clustered randomized controlled trial to imProve treatment with AntiCoagulanTs in patients with atrial fibrillation.

Duke Clinical Research Institute12 个研究点 分布在 1 个国家目标入组 2,800 人开始时间: 2015年3月26日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
2,800
试验地点
12
主要终点
Change in proportion of patients taking oral anti coagulant from baseline to one year

研究概览

简要总结

Prior observational studies such as the Rely-AF registry have demonstrated that the proportion of eligible patients with a diagnosis of atrial fibrillation receiving oral anticoagulation is sub-optimal. The registry also demonstrated poor levels of INR control, particularly in South Asian patients. IMPACT study aims to improve the proportion of eligible patients on oral anticoagulants and optimize oral anticoagulation in atrial fibrillation patients. We hypothesize that an educational intervention directed towards the physicians and patients will increase the proportion of eligible patients who are treated with oral anticoagulation and will further increase patient adherence and persistence to oral anticoagulation for 1 year. We propose to evaluate the intervention using a cluster randomized design, with the hospital being the unit of randomization. Physicians in the ’intervention’ clusters will receive the latest guidelines (ACC/AHA and NICE) on the management of atrial fibrillation and attend online webinars and live summits. At the patient level, patients will receive educational material on atrial fibrillation, its treatment and the importance of adhering to therapy. Furthermore, the patients will be followed up by trained non-physician health workers, who will facilitate regular follow-ups and improve communication between physicians and patients. We will recruit 600 patients and work with different  hospitals across India for the IMPACT study. Patients will be followed up for 1 year.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • PAROXYSMAL PERSISTENT OR PERMANENT ATRIAL FIBRILLATION WITH A 12 LEAD ECG SHOWING ATRIAL FIBRILLATION AND NOT DUE TO REVERSIBLE CAUSE LIKE POST CABG.
  • PATIENTS WITH AT LEAST TWO CHA2DS2VASc RISK FACTORS.

排除标准

  • MECHANICAL PROSTHETIC VALVE.
  • CLINICALLY UNSTABLE AT THE TIME OF ENROLLMENT(ie WITH ONGOING SHOCK).
  • TERMINAL ILLNESS AND/OR COMFORT CARE.
  • UNABLE TO PROVIDE CONSENT.
  • UNABLE TO HAVE ONE YEAR OF FOLLOW UP FOR AN REASON.
  • CLEAR AND ABSOLUTE CONTRAINDICATION TO ORAL COAGULATION (FOR EXAMPLE, ACTIVE BLEEDING OR RECENT LIFE THREATENING BLEEDING SUCH AS ICH).
  • ATRIAL FLUTTER ENROLLMENT IN ANOTHER CLINICAL TRIAL NO RECURRENCE OF ATRIAL FIBRILLATION AFTER ABLATION.

结局指标

主要结局

Change in proportion of patients taking oral anti coagulant from baseline to one year

时间窗: Telephonic calls or patient visits at 1 month 3 month 6 month 9 month and 12 month.

次要结局

  • Change in proportion of patients who continue anti coagulation for one year.(Change in proportion of patients who are not on anti coagulation at baseline and are on anti coagulation at one year.)

研究者

申办方类型
Research institution

研究点 (12)

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