Rao Meena P, Ciobanu Andrea O, Lopes Renato D, Fox Kathleen A, Xian Ying, Pokorney Sean D, Al-Khalidi Hussein R, Jiang Jei, Kamath Deepak Y, Berwanger Otavio, Xavier Denis, Bahit Cecilia M, Tajer Carlos, Vinereanu Dragos, Huo Yong, Granger Christopher B
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
University of Medicine and Pharmacy Carol Davila, Bucharest, Romania.
Am Heart J. 2016 Jun;176:107-13. doi: 10.1016/j.ahj.2016.03.011. Epub 2016 Mar 21.
Atrial fibrillation (AF) is common, increasing as the population ages, and a major cause of embolic stroke. While oral anticoagulation (OAC) is highly effective at preventing stroke in patients with AF, it continues to be underused in eligible patients worldwide. The objective of this prospective, cluster randomized controlled trial (IMPACT-AF; ClinicalTrials.gov #NCT02082548) is to determine whether a comprehensive customized intervention will increase the rate and persistence of use of OAC in patients with AF. IMPACT-AF will be conducted in approximately 50 centers in 5 low- to middle-income countries. Before randomization, sites within countries will be paired to match in size, practice type and baseline rate of OAC use. Site pairs will be randomized to intervention versus control. In total, 40 to 70 patients with AF and at least 2 CHA2DS2-VASc risk factors will be enrolled at each site using a consecutive enrollment strategy, with the goal of capturing actual practice patterns. We aim for patients with a new diagnosis of AF to comprise at least 30% of the study cohort. Assuming an average baseline OAC use of 60% and a post-intervention use of 70% with a post-control rate of 60%, there will be roughly 94-98% power with 25 clusters per group (intracluster correlation coefficient of 0.02). While this trial focuses on improving treatment use and reducing preventable strokes, we also aim to better understand the reasons for OAC underuse. This will improve the intervention with the goal of creating educational recommendations to improve care for patients with AF.
心房颤动（AF）很常见，且随着人口老龄化而增加，是栓塞性中风的主要原因。虽然口服抗凝药（OAC）在预防AF患者中风方面非常有效，但在全球符合条件的患者中仍未得到充分使用。这项前瞻性、整群随机对照试验（IMPACT-AF；ClinicalTrials.gov #NCT02082548）的目的是确定全面的定制干预措施是否会提高AF患者使用OAC的比例和持续性。IMPACT-AF将在5个低收入和中等收入国家的约50个中心进行。在随机分组之前，各国的研究地点将进行配对，以使其在规模、执业类型和OAC使用的基线率方面相匹配。地点对将被随机分为干预组和对照组。每个地点将采用连续入组策略，总共招募40至70名患有AF且至少有2个CHA2DS2-VASc危险因素的患者，目标是捕捉实际的实践模式。我们的目标是新诊断为AF的患者至少占研究队列的30%。假设平均基线OAC使用率为60%，干预后使用率为70%，对照组后使用率为60%，每组25个整群时，检验效能约为94%-98%（组内相关系数为0.02）。虽然这项试验侧重于改善治疗的使用并减少可预防的中风，但我们也旨在更好地了解OAC未充分使用的原因。这将改进干预措施，目标是制定教育建议以改善对AF患者的护理。
