Department of Thrombosis and Hemostasis, Leiden University Medical Centre, Leiden, The Netherlands
Department of Cardiology, Rijnstate, Arnhem, The Netherlands.
BMJ Open. 2020 Aug 24;10(8):e036220. doi: 10.1136/bmjopen-2019-036220.
Anticoagulation therapy is pivotal in the management of stroke prevention in atrial fibrillation (AF). Prospective registries, containing longitudinal data are lacking with detailed information on anticoagulant therapy, treatment adherence and AF-related adverse events in practice-based patient cohorts, in particular for non-vitamin K oral anticoagulants (NOAC). With the creation of DUTCH-AF, a nationwide longitudinal AF registry, we aim to provide clinical data and answer questions on the (anticoagulant) management over time and of the clinical course of patients with newly diagnosed AF in routine clinical care. Within DUTCH-AF, our current aim is to assess the effect of non-adherence and non-persistence of anticoagulation therapy on clinical adverse events (eg, bleeding and stroke), to determine predictors for such inadequate anticoagulant treatment, and to validate and refine bleeding prediction models. With DUTCH-AF, we provide the basis for a continuing nationwide AF registry, which will facilitate subsequent research, including future registry-based clinical trials.
The DUTCH-AF registry is a nationwide, prospective registry of patients with newly diagnosed 'non-valvular' AF. Patients will be enrolled from primary, secondary and tertiary care practices across the Netherlands. A target of 6000 patients for this initial cohort will be followed for at least 2 years. Data on thromboembolic and bleeding events, changes in antithrombotic therapy and hospital admissions will be registered. Pharmacy-dispensing data will be obtained to calculate parameters of adherence and persistence to anticoagulant treatment, which will be linked to AF-related outcomes such as ischaemic stroke and major bleeding. In a subset of patients, anticoagulation adherence and beliefs about drugs will be assessed by questionnaire.
This study protocol was approved as exempt for formal review according to Dutch law by the Medical Ethics Committee of the Leiden University Medical Centre, Leiden, the Netherlands. Results will be disseminated by publications in peer-reviewed journals and presentations at scientific congresses.
Trial NL7467, NTR7706 (https://www.trialregister.nl/trial/7464).
抗凝治疗在预防心房颤动（AF）中的卒中管理中至关重要。前瞻性登记处缺乏包含详细抗凝治疗、治疗依从性和 AF 相关不良事件信息的纵向数据，特别是在基于实践的患者队列中，对于非维生素 K 口服抗凝剂（NOAC）更是如此。通过创建全国性的纵向 AF 登记处 DUTCH-AF，我们旨在提供临床数据并回答关于（抗凝）管理随时间推移以及在常规临床护理中新诊断 AF 患者临床过程的问题。在 DUTCH-AF 中，我们目前的目标是评估抗凝治疗不依从和不持续对临床不良事件（例如出血和卒中）的影响，确定导致这种不充分抗凝治疗的预测因素，并验证和改进出血预测模型。通过 DUTCH-AF，我们为持续的全国性 AF 登记处提供了基础，这将促进随后的研究，包括未来基于登记处的临床试验。
DUTCH-AF 登记处是一项全国性、前瞻性的新诊断“非瓣膜性”AF 患者登记处。患者将从荷兰的初级、二级和三级保健机构招募。该初始队列的目标是招募 6000 名患者，并至少随访 2 年。将登记血栓栓塞和出血事件、抗血栓治疗变化和住院情况的数据。将获得药房配药数据，以计算抗凝治疗依从性和持续性参数，这些参数将与 AF 相关的结局（如缺血性卒中和大出血）相关联。在患者的亚组中，将通过问卷调查评估抗凝治疗的依从性和对药物的信念。
根据荷兰法律，这项研究方案被莱顿大学医学中心医学伦理委员会批准为豁免正式审查，莱顿，荷兰。结果将通过在同行评议期刊上发表文章和在科学大会上发表演讲来传播。
NL7467，NTR7706（https://www.trialregister.nl/trial/7464）。
