Chinese acute ischemic stroke treatment outcome registry (CASTOR): protocol for a prospective registry study on patterns of real-world treatment of acute ischemic stroke in China

Abstract

Rationale: Stroke 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.

Aims: The 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.

Design: CASTOR 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.

Outcome: The 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.

Discussion: In 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.

Keywords: Acute ischemic stroke; Cost-effectiveness; Cost-utility; Outcome; Protocols; Registry study; Therapy.

Fig. 1

Study schedule of assessments. GCS, Glasgow coma Scale; NIHSS, National Institutes of Health Stroke Scale; mRS, Modified Rankin Scale; EQ-5D, EuroQol-5 Dimensions; MMSE, Mini-mental state examination; TOAST, Trial of Org 10,172 in Acute Stroke Treatment; ECG, Electrocardiograph. a. Visit 2 could be skipped if the patient is discharged at that time; b. optional items; c. It includes stroke, hypertension, diabetes, dyslipidemia, coronary heart disease, atrial fibrillation, carotid plaques, and tumors; d. MMSE is available for outpatient visits of visit 4; e. It includes body temperature, pulse, respiration and blood pressure, and body temperature should be collected at admission and 24 h after admission at visit 1; f. It includes examinations of blood routine test, blood glucose, blood lipids, liver and renal functions, myocardial enzymes, serum electrolytes, and coagulation function; g. It refers to the specific treatments for AIS, and the non-specific treatments will be recorded in the item “combined medications”; h. It is recorded from the time of obtaining the signed informed consent form to 30 days after the last administration; i. It refers to the direct costs, including the direct medical costs and the direct non-medical costs