title: Re-evaluate the Efficacy and Safety of Human Urinary Kallidinogenase (RESK): Protocol for an Open-Label, Single-Arm, Multicenter Phase IV Trial for the Treatment of Acute Ischemic Stroke in Chinese Patients.
abstract: Acute ischemic stroke (AIS) is a major medical challenge in China. Thrombolytic drugs recommended for the treatment of AIS usually have a narrow time window. Human urinary kallidinogenase (HUK) was approved by the China Food and Drug Administration (CFDA) in 2005 for the treatment of mild to moderate AIS, and it is thus widely used in China. However, large-scale clinical study data for a more complete understanding of various aspects of its safety and efficacy characteristics are still unavailable. The ongoing Reevaluate the Efficacy and Safety of Human Urinary Kallidinogenase (RESK) trial is designed to reevaluate the safety and efficacy of HUK in Chinese patients with AIS. RESK is an open-label, single-arm, multicenter phase IV trial. A total of 2186 Chinese patients with AIS will be enrolled. All patients receive HUK by intravenous drip once daily for 21 consecutive days. The study has registered on ClinicalTrials.gov (NCT02562183). On 8 September 2016, 202 patients have been enrolled. Primary outcome includes the frequency and severity of adverse events. Secondary outcomes include functional improvement measured by the National Institutes of Health Stroke Scale, Barthel index, and modified Rankin Scale, and recurrence rate of ischemic stroke. Data from large-scale clinical studies are still unavailable concerning the post-marketing use of HUK. The RESK study is designed to provide a comprehensive reevaluation of the safety and efficacy of HUK in Chinese patients with AIS.
  
  
  
  The study has registered on ClinicalTrials.gov (NCT02562183).
authors.affiliation: Department of Neurology, Peking Union Medical College Hospital, Beijing, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Ni
authors.affiliation: Medical Affairs, Techpool Bio-Pharma Co., Ltd, Guangzhou, China.
authors.forename: Jiazhi
authors.initials: J
authors.lastname: Qu
authors.affiliation: Department of Neurology, Peking Union Medical College Hospital, Beijing, China.
authors.forename: Ming
authors.initials: M
authors.lastname: Yao
authors.affiliation: Medical Affairs, Techpool Bio-Pharma Co., Ltd, Guangzhou, China.
authors.forename: Zhijun
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: Data Statistics Centre, Shanghai Knowlands MedPharm Consulting Co., Ltd, Shanghai, 201101, China.
authors.forename: Xihua
authors.initials: X
authors.lastname: Zhong
authors.affiliation: Department of Neurology, Peking Union Medical College Hospital, Beijing, China. liyingcui1234@163.com.|Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No. 1, Shuaifuyuan, Dongcheng District, Beijing, 100730, China. liyingcui1234@163.com.
authors.forename: Liying
authors.initials: L
authors.lastname: Cui
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult; D061605:Administration, Intravenous; D002545:Brain Ischemia / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy; D002681:China; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000009:adverse effects; D005500:Follow-Up Studies; D008279:Magnetic Resonance Imaging; D012720:Severity of Illness Index; D020521:Stroke / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000209:etiology; D020840:Tissue Kallikreins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D012107:Research Design
chemical_list: D005343:Fibrinolytic Agents; D020840:Tissue Kallikreins
keywords: Acute ischemic stroke; Acute stroke therapy; Protocols; Registry study