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
Tóm tắt
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. Trial registration: The study has registered on
ClinicalTrials.gov
(NCT02562183).
Tài liệu tham khảo
Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S. Heart disease and stroke statistics—2014 update. Circulation. 2014;129
Jauch EC, Saver JL, Adams HP, Bruno A, Demaerschalk BM, Khatri P, McMullan PW, Qureshi AI, Rosenfield K, Scott PA. Guidelines for the early management of patients with acute ischemic stroke a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44:870–947.
Eissa A, Krass I, Bajorek B. Barriers to the utilization of thrombolysis for acute ischaemic stroke. J Clin Pharm Ther. 2012;37:399–409.
Wang Y, Liao X, Zhao X, Wang DZ, Wang C, Nguyen-Huynh MN, Zhou Y, Liu L, Wang X, Liu G, Li H. Using recombinant tissue plasminogen activator to treat acute ischemic stroke in China: analysis of the results from the Chinese National Stroke Registry (CNSR). Stroke. 2011;42:1658–64.
Zhao L, Zhao Y, Wan Q, Zhang H. Urinary kallidinogenase for the treatment of cerebral arterial stenosis. Drug Des Devel Ther. 2015;9:5595–600.
Ding D, Lv C, Ding M, Su B, Chen F. A multicenter, randomized, double-blinded and placebo-controlled study of acute brain infarction treated by human urinary kallidinogenase. Chin J Neurol. 2007;40:306–10.
Chinese Society of Neurology, Cerebrovascular Disease Group of the Chinese Society of Neurology. Chinese guidelines of diagnosis and treatment for acute ischemic stroke (2014). Chin J Neurol. 2015;48:246–57.
Zhang C, Tao W, Liu M, Wang D. Efficacy and safety of human urinary kallidinogenase injection for acute ischemic stroke: a systematic review. Chin J Evid-based Med. 2012;12:570–6.
Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. 1974;2:81–4.
Brott T, Adams Jr HP, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989;20:864–70.
Rankin J. Cerebral vascular accidents in patients over the age of 60. II. Prognosis. Scott Med J. 1957;2:200–15.
Strbian D, Meretoja A, Ahlhelm F, Pitkäniemi J, Lyrer P, Kaste M, Engelter S, Tatlisumak T. Predicting outcome of IV thrombolysis-treated ischemic stroke patients the DRAGON score. Neurology. 2012;78:427–32.