Abstract
RationaleStroke presents a serious health problem in China. Despite progresses made in recent years, there is still a lack of effective treatments for acute ischemic stroke (AIS) in clinical practices.AimsThe Chinese Acute Ischemic Stroke Treatment Outcome Registry (CASTOR) is designed to evaluate the patterns and cost-effectiveness of current treatments for AIS in real-world settings in China.DesignCASTOR is a prospective, multi-center study registered with ClinicalTrials.gov (NCT02470624) with a target sample size of 10,000 patients who are experiencing AIS. The patients are treated for AIS following the Chinese stroke guideline and local practice. Real-world data on treatment regimens, outcomes and costs are collected at baseline (Visit 1) and during subsequent visits (Visit 2 to Visit 5) after medication treatments.OutcomeThe primary objective of the present study is to analyze the current treatment status of AIS in real world settings. The secondary objectives include: 1) to compare the effectiveness of common treatment regimens, 2) to analyze the cost-effectiveness of different treatment regimens for AIS, 3) to analyze the incidence of adverse events and complications in enrolled patients with AIS, 4) to analyze the effect of Trial of Org 10,172 in Acute Stroke Treatment (TOAST) classification on the specific therapies during acute phase treatment period.DiscussionIn face of changing treatment patterns and increasing demand from medical insurers for cost-effectiveness data in China, a large-scale registry study examining the real-world patterns of AIS in hospitals is needed. The CASTOR study will help to find favorable cost-utility treatment regimens for AIS and improve the overall treatment outcome of Chinese patients with AIS.
Highlights
Stroke is one of the leading causes of death and long-term disability worldwide [1] and in China [2, 3]
In patients with ischemic stroke treated with tissue plasminogen activator, disturbances of consciousness and increasing age are associated with increased in-hospital mortality [14]
Considering the study may last for several years, retrospective modifications may be needed when interim data are collected
Summary
The CASTOR is a prospective, multi-center clinical registry with a large sample size. It is designed to investigate the drug treatments for AIS in the real-world settings and to find high cost-utility treatments for AIS. A registry could reveal the treatment patterns, such as switching therapies during follow-up and concomitant medications in a real-world setting [29], which are unlikely to be obtained in clinical trials. The CASTOR will enroll as many patients as possible, which contribute to finding some high cost-utility treatments of AIS and improving the outcomes of patients with AIS in China. Study sample size The registry must have a sufficiently large sample size to be representative of the real-world setting. Additional file 1: Standard Operation Procedures (SOPs) of Chinese Acute Ischemic Stroke Treatment Outcome Registry (CASTOR).
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