Efficacy and Safety of Human Urinary Kallidinogenase Combined With Reteplase Intravenous Thrombol… (NCT07483281) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of Human Urinary Kallidinogenase Combined With Reteplase Intravenous Thrombolysis in the Treatment of Acute Ischemic Stroke
China220 participantsStarted 2026-05-01
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 6 ≤NIHSS≤ 16
✓. Meet the clinical thrombolysis indications in the Chinese Guidelines for the Diagnosis and Treatment of Ischemic Stroke and receive reteplase intravenous thrombolysis
✓. Have provided signed written informed consent from the patient or the patient's legal representative
Exclusion criteria
✕. 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
✕. Patients with fracture, claudication and other factors affecting functional outcome score upon admission
What they're measuring
1
Proportion of patients with modified Rankin Scale (mRS) 0-1
. Use of Edaravone Injection, Edaravone Dexborneol Injection, Sublingual Edaravone Dexborneol, Butylphthalide Injection or Capsules after the onset of the current episode
✕. Severe uncontrolled hypertension: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg
✕. History of severe food or drug allergies, or prior allergy or intolerance to urinary kallidinogenase for injection