This study is a multicentre, randomized, blinded-endpoint trial that aims to evaluate the efficacy and safety of human urinary kallidinogenase combined with reteplase intravenous thrombolysis in the treatment of acute ischemic stroke
Meet the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023
Age ≥ 18 years
The time from last known well to treatment is within 4.5 hours
First-ever ischemic stroke or have history of ischemic stroke but mRS≤1 before onset
Preoperative non-contrast head CT shows Alberta Stroke Program Early CT Score (ASPECTS) ≤ 6
Presence of contraindications to intravenous thrombolysis
Patients who have been on angiotensin-converting enzyme inhibitor (ACEI) drugs and within 5 half-lives (according to the specific drug instructions) before initiate Human Urinary Kallidinogenase treatment
Planed for endovascular treatment
Parallel
Human Urinary Kallidinogenase
DrugIntravenous injections of urinary kallidinogenase (0.15 PNA units) dissolved in 100 ml of normal saline, administered via slow intravenous drip over no less than 50 minutes,once a day. The solvent can be increased and/or slowed down according to the patient's condition for 8±1 days
Clinical Routine Treatment
Other interventionConventional therapy of acute ischemic stroke after based on Chinese guidelines
Proportion of patients with modified Rankin Scale (mRS) 0-1
mRS scores range from 0 to 6. 0=no symptoms,1 = symptoms without clinically significant disability,2 = slight disability,3 = moderate disability,4 = moderately severe disability,5 = severe disability; and 6 = death
ordinal distribution of modified Rankin Scale (mRS)
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Proportion of patients with modified Rankin Scale (mRS) 0-2
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
occurrence of early neurological improvement (ENI)
ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score or NIHSS score ≤ 1
change of National Institute of Health stroke scale (NIHSS) score
NIHSS ranges from 0 to 42, a low value represents a better outcome
Rate of symptomatic intracranial hemorrhage (sICH)
sICH was defined as any evidence of bleeding on the head computed tomographic scan associated with clinically significant neurological deterioration
Rate of any bleeding events
Including skin and mucosal bleeding, gingival bleeding, bleeding at other organ sites, and other types of hemorrhage
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This trial is not recruiting at the moment. You can still explore other options:
