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

AbstractAcute 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 (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 wi...
Source: Translational Stroke Research - Category: Neurology Source Type: research

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CONCLUSIONS: Although statistical significance was not reached, the efficacy of prasugrel was potentially different between stroke subtypes, warranting further studies. PMID: 32493881 [PubMed - as supplied by publisher]
Source: Journal of Atherosclerosis and Thrombosis - Category: Cardiology Tags: J Atheroscler Thromb Source Type: research
Atrial fibrillation is the most common sustained cardiac arrhythmia in the general population. In western countries with aging populations, atrial fibrillation poses a significant health concern, as it is associated with a high risk of thromboembolism, stroke, congestive heart failure, and myocardial infarction. Thrombi are generated in the left atrial appendage, and subsequent embolism into the cerebral circulation is a major cause of ischemic stroke. Therefore, patients have a lifetime risk of stroke, and those at high risk, defined as a CHA2DS2-VASc2 (congestive heart failure, hypertension, age>75 years, diabetes mel...
Source: Cardiology in Review - Category: Cardiology Tags: Review Articles Source Type: research
We report the results of transcranial ultrasound monitoring in three patients with intracranial arterial stenosis of the middle cerebral artery treated with the only drug-eluting balloon certificated for intracranial use in highly symptomatic intracranial arterial stenosis, ELUTAX "3" (AR Baltic Medical). We performed transcranial Doppler ultrasounds 24 h, 72 h, 10 days, 15 days and 30 days after the angioplasty, thereby measuring mean flow velocity (MFV) in the maximum stenosis area in patients with symptomatic steno-occlusive disease of the middle cerebral artery treated with ELUTAX "3". Two patients ...
Source: Interventional Neuroradiology - Category: Radiology Tags: Interv Neuroradiol Source Type: research
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Source: Current Treatment Options in Neurology - Category: Neurology Source Type: research
Editor's Summary by Angel Desai, MD, JAMA Fishbein Fellow, for the Journal of the American Medical Association's June 2, 2020 issue
Source: JAMA: This Week's Audio Commentary - Category: General Medicine Authors: Source Type: podcasts
This cohort study estimates associations between intravenous tissue plasminogen activator (tPA) door-to-needle times of less than 4.5 hours for acute ischemic stroke and 1-year mortality or readmission among Medicare beneficiaries aged 65 years or older.
Source: JAMA - Category: General Medicine Source Type: research
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Source: JAMA - Category: General Medicine Source Type: research
AbstractThe cerebrovascular effects of a failing heart-pump are largely unknown. Chronic heart failure (HF) might cause pre-conditioning effect on cerebral hemodynamics but not study so far in acute stroke. We aimed to investigate if HF induces effects in dynamic cerebral autoregulation (CA), within 6  h of symptom-onset through chronic stage of ischemic stroke. We enrolled 50 patients with acute ischemic stroke. Groups with (N = 8) and without HF and 20 heathy controls were compared. Arterial blood pressure (Finometer) and cerebral blood flow velocity (transcranial Doppler) were monitored w ithin 6 and ...
Source: Journal of Thrombosis and Thrombolysis - Category: Hematology Source Type: research
Authors: Poznyak AV, Zhang D, Grechko AV, Wu WK, Orekhov AN Abstract Atherosclerosis is a major cause of disease-related mortality around the globe. The main characteristic of the disease is an accumulation of plaque on the arterial wall and subsequent erosion or rupture of some plaques. Atherosclerosis often leads to cardiovascular disease and such acute complications as myocardial infarction or ischaemic stroke due to thrombus formation. Most recent advances in atherosclerotic research state that the modifications of low- density lipoprotein (LDL) are one of the most significant stages in the disease initiation, ...
Source: Minerva Cardioangiologica - Category: Cardiology Tags: Minerva Cardioangiol Source Type: research
Abstract Cardiogenic stroke (CS), characteristic causes of which include atrial fibrillation (AF) and right-to-left shunting due to a patent foramen ovale (PFO), has a well-known tendency to be associated with a more extensive ischemic area. This may result in severe neurological damage, and require strict life-long antithrombotic therapy. However, the fact that some patients have problems complying with the requirement for extended oral antithrombotic treatment has motivated the development of alternative approaches for stroke prevention. Heart structures such as the left atrial appendage (LAA) and PFO are potent...
Source: Journal of Cardiology - Category: Cardiology Authors: Tags: J Cardiol Source Type: research
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