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Tests urinary kallidinogenase in people with stroke from narrowed large arteries

Tests urinary kallidinogenase in adults with acute ischemic stroke from artery narrowing.

Plain-language title generated from the registry record
Registry title: Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke

Key facts

Where
Changchun, ChinaSee the site

Where in China

  • First Hospital of Jilin UniversityChangchun, ChinaNo longer taking part

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Trial details

Who runs it
Yi Yang
Trial code
NCT06137300
Record updated
28 February 2024
Original description
The purpose of this study is to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.Read full original descriptionShow less

Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke:a Multicentre, Prospective, Randomised, Open-label, Blinded-Endpoint Trial

The purpose of this study is to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.

Inclusion: Age ≥18 years old; Acute anterior circulation large artery atherosclerotic cerebral infarction (according to TOAST classification) within 48h of onset; NIHSS score ≥6, ≤15; Moderate to severe stenosis or occlusion of offending vessels; The mRS Score ≤2 before onset; Subjects or their legal representatives agreed to the treatment and signed the informed consent form.

Exclusion: Patients who planned or had received emergency reperfusion therapy (including intravenous thrombolysis and emergency thrombectomy); Patients who previously received angiotensin-converting enzyme inhibitor (ACEI) drugs regularly; Participating in other clinical investigators, or had participated in other clinical investigators within 3 months before enrollment; Refractory hypertension: systolic blood pressure ≥200 mmHg or diastolic blood pressure ≥110 mmHg; hypotension: systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg; Cardioembolic stroke or high-risk factors of cardioembolic stroke identified by investigators (atrial fibrillation, cardiac mural thrombus, cardiomyopathy, etc.); Other conditions considered by the investigator to be inappropriate for enrollment; Liver dysfunction (ALT/AST >1.5 × upper limit of normal [ULN]), renal dysfunction (Cr >1 × ULN); Coagulopathy (prolonged INR (>1.5) or prolonged APTT (>2 folds); Transient ischemic attack; Severe disturbance of consciousness:GCS ≤8; Special populations such as pregnant and lactating women, patients with life expectancy less than 3 months, or patients unable to complete the study for other reasons; Unwilling to be followed up or poor treatment compliance.

ClinicalTrials.gov NCT06137300