Anticoagulation in ICH Survivors for Prevention and Recovery (ASPIRE)

ICH幸存者的抗凝治疗以预防和恢复（ASPIRE）

基本信息

批准号：
10170976
负责人：
Hooman Kamel
金额：
$ 50.28万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-06-01 至 2021-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10170976
关键词：
2019-nCoV Acute Acute Brain Injuries Address Admission activity Affect Anticoagulant therapy Anticoagulants Anticoagulation Aspirin Atrial Fibrillation Blinded Blood Brain Injuries Brain hemorrhage C-reactive protein COVID-19 COVID-19 pandemic Cerebral Infarction Cerebral hemisphere hemorrhage Cessation of life Clinical Clinical Trials Collaborations Communities Complication Computer Interface Critical Care Critical Illness Data Data Set Decontamination Detection Devices Disease Double-Blind Method Electromagnetics Endothelium Enrollment Face Ferritin Fibrin fragment D Foundations Fright Functional disorder Future General Hospitals Guidelines Head Hemorrhage Image Infection Inflammatory Infrastructure Inpatients Intensive Care Units Intervention Studies Intracranial Hemorrhages Ischemic Stroke Knowledge Lead Link Liquid substance Magnetic Resonance Imaging Massachusetts Measures Medical Mission Multicenter Studies National Institute of Neurological Disorders and Stroke Nature Neuraxis Neurologic Neurological Models Oral Outcome Patient-Focused Outcomes Patients Phase Phenotype Physiological Prevention Prevention therapy Prevention trial Preventive Intervention Protocols documentation Public Health Randomized Randomized Clinical Trials Recording of previous events Recovery Recurrence Reporting Research Design Risk Risk Factors Safety Serological Severities Site Stroke Stroke prevention Survivors Symptoms Tablet Computer Testing Thrombophilia Thrombosis United States National Institutes of Health Ventilator Work Writing antimicrobial base body system brain health clinical care clinical practice clinical risk cohort comorbidity coronavirus disease cryogenics disability epidemiological model falls functional outcomes functional status heart rhythm high risk improved improved outcome instrument mortality neuroimaging novel patient oriented patient population portability predictive modeling prevent primary outcome public health relevance recruit secondary endpoint stroke risk

项目摘要

Atrial fibrillation, the most common heart-rhythm disorder, increases the risk of ischemic stroke by 3- to 5-fold. Anticoagulant therapy has been proven to prevent 60-80% of ischemic strokes that would otherwise occur from atrial fibrillation. Patients with a history of intracerebral hemorrhage have been excluded from clinical trials of anticoagulation in patients with atrial fibrillation. Whether to use anticoagulation in these patients represents a major knowledge gap and clinical dilemma. Many clinicians fear that the proven benefit of anticoagulation in preventing ischemic stroke will be offset by an increase in hemorrhagic stroke. Preliminary data from multicenter studies indicate that, in patients with atrial fibrillation and recent intracerebral hemorrhage, anticoagulation is associated with a decreased risk of ischemic stroke and overall mortality with no offsetting increase in the burden of recurrent hemorrhagic stroke. These pilot data also suggest that anticoagulation is associated with better long-term functional outcomes. Although these data are compelling, they are observational findings and subject to confounding and bias. In clinical practice, about one-third of patients with intracerebral hemorrhage and atrial fibrillation receive anticoagulation and the remainder receive antiplatelet therapy such as aspirin. Current clinical guidelines call for randomized, blinded clinical trials to provide high-quality evidence to determine the best treatment. The argument for a clinical trial is made more compelling by the advent of apixaban, a relatively new oral anticoagulant drug, which was found to have similar bleeding risks as aspirin in a recent head-to-head trial. This application is for a multicenter, double-blinded, randomized clinical trial of apixaban versus aspirin in patients with atrial fibrillation and a recent intracerebral hemorrhage. Seven hundred patients will be recruited and followed for 1 to 3 years at 125 sites in NINDS StrokeNet. The aim of the study will be to test the hypothesis that apixaban improves outcomes compared to aspirin. The primary outcome will be any stroke (ischemic or hemorrhagic) or death. This composite outcome addresses both efficacy and safety, and represents a clinically meaningful endpoint often used in stroke prevention trials. The secondary endpoint will be functional status, as measured by the modified Rankin Scale score. This secondary endpoint will be used to test the hypothesis that apixaban not only reduces stroke recurrence but also the severity of any strokes that do occur. If confirmed, this novel finding would provide an important patient-centered context for the primary trial results. This proposal offers an opportunity to improve the outcomes of patients with intracerebral hemorrhage by focusing on their brain health both in the acute setting and over the long term. The impact of this study is that its successful completion, regardless of the direction of its results, would immediately guide clinical care and set the stage for future trials of antithrombotic therapy in patients with atrial fibrillation and other types of bleeding.

心房颤动是最常见的心脏节律障碍，使缺血性中风的风险增加了3至5倍。事实证明，抗凝治疗可预防60-80％的缺血性中风，而心房颤动会发生。在心房颤动患者的抗凝临床试验中排除了脑出血史的患者。是否在这些患者中使用抗凝作用代表了主要的知识差距和临床困境。许多临床医生担心，抗凝性抗凝性中风的可靠益处将被出血性中风的增加所抵消。来自多中心研究的初步数据表明，在心房颤动和最近脑部出血的患者中，抗凝抗凝性与缺血性中风的风险降低和总体死亡率降低，而复发性出血性中风的负担没有增加。这些试点数据还表明，抗凝与更好的长期功能结果有关。尽管这些数据令人信服，但它们是观察性的发现，并且存在混杂和偏见。在临床实践中，大约三分之一的脑出血和心房颤动患者接受抗凝治疗，其余的患者接受抗血小板治疗，例如阿司匹林。当前的临床准则要求进行随机，盲目的临床试验，以提供高质量的证据以确定最佳治疗方法。临床试验的论点更具吸引力，这是一种相对较新的口服抗凝剂药物的出现，在最近的一项头对头试验中，发现与阿司匹林具有类似的出血风险。该应用是针对心房颤动和最近脑内出血的多中心，双盲，随机临床试验与阿司匹林的随机临床试验。在Ninds Strokenet的125个地点，将招募700名患者，并在125个地点招募1至3年。该研究的目的是测试与阿司匹林相比改善结果的假设。主要结果将是任何中风（缺血或出血）或死亡。该综合结果既解决疗效和安全性，又代表了预防试验中经常使用的临床意义。次要终点将是功能状态，如修改后的Rankin量表得分所测量。该次要终点将用于检验以下假设：apixaban不仅减少了中风复发，而且还会降低确实发生的任何中风的严重性。如果得到证实，这一新发现将为主要试验结果提供重要的以患者为中心的环境。该提案提供了一个机会，可以通过在急性环境和长期内专注于脑部出血的患者的结局。这项研究的影响是，无论结果的方向如何，它都将成功完成临床护理，并为心房颤动和其他类型的出血患者的抗血栓疗法的未来试验奠定了基础。

项目成果

期刊论文数量（42）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Disability Status and Secondary Prevention Among Survivors of Stroke: A Cross-Sectional Analysis of the 2011 to 2018 National Health and Nutrition Examination Survey.

DOI：
10.1161/jaha.123.030869
发表时间：
2023-12-05
期刊：
Journal of the American Heart Association
影响因子：
5.4
作者：
通讯作者：

The Authors Reply.

DOI：
10.1038/ki.2015.131
发表时间：
2015-07
期刊：
Kidney international
影响因子：
19.6
作者：
Dong Z
通讯作者：
Dong Z

Anticoagulation after intracerebral hemorrhage: a perfect clinical scenario for genetics-based precision medicine.

脑出血后抗凝：基于遗传学的精准医学的完美临床方案。

DOI：
10.2217/pgs-2019-0181
发表时间：
2020
期刊：
Pharmacogenomics
影响因子：
2.1
作者：
Brown,StacyC;Sheth,KevinN;Falcone,GuidoJ
通讯作者：
Falcone,GuidoJ

Effect of Intensive Blood Pressure Control on Incident Stroke Risk in Patients With Mild Cognitive Impairment.

DOI：
10.1161/strokeaha.122.038818
发表时间：
2022-07
期刊：
STROKE
影响因子：
8.3
作者：
de Havenon, Adam;Sharma, Richa;Falcone, Guido J.;Prabhakaran, Shyam;Sheth, Kevin N.
通讯作者：
Sheth, Kevin N.

StrokeClassifier: Ischemic Stroke Etiology Classification by Ensemble Consensus Modeling Using Electronic Health Records.

StrokeClassifier：使用电子健康记录通过集成共识模型对缺血性中风病因进行分类。

DOI：
10.21203/rs.3.rs-3367169/v1
发表时间：
2023
期刊：
Research square
影响因子：
0
作者：
Lee,Ho-Joon;Schwamm,LeeH;Sansing,Lauren;Kamel,Hooman;deHavenon,Adam;Turner,AshbyC;Sheth,KevinN;Krishnaswamy,Smita;Brandt,Cynthia;Zhao,Hongyu;Krumholz,Harlan;Sharma,Richa
通讯作者：
Sharma,Richa