Efficacy and Safety of Human Urinary Kallidinogenase Combined With Reteplase Intravenous Thrombolysis in the Treatment of Acute Ischemic Stroke
KREATE
1 other identifier
interventional
220
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2026
CompletedFirst Posted
Study publicly available on registry
March 19, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 18, 2028
March 30, 2026
March 1, 2026
1.8 years
March 16, 2026
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
90 days
Secondary Outcomes (8)
ordinal distribution of modified Rankin Scale (mRS)
90 days
Proportion of patients with modified Rankin Scale (mRS) 0-2
90 days
occurrence of early neurological improvement (ENI)
24 、24-48 hours
change of National Institute of Health stroke scale (NIHSS) score
24 、24-48 hours
change in National Institute of Health stroke scale (NIHSS) score
8±1 days
- +3 more secondary outcomes
Other Outcomes (2)
Rate of symptomatic intracranial hemorrhage (sICH)
48 hours
Rate of any bleeding events
8±1 days
Study Arms (2)
Intervention group:Human Urinary Kallidinogenase + Clinical Routine Treatment
EXPERIMENTALIntravenous injections of Human urinary kallidinogenase (0.15 PNA units) dissolved in 100 ml of normal saline once a day for 8±1 days
Control group: Clinical Routine Treatment
OTHERConventional therapy of acute ischemic stroke after based on Chinese guidelines
Interventions
Intravenous 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
Conventional therapy of acute ischemic stroke after based on Chinese guidelines
Eligibility Criteria
You may qualify if:
- 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
- ≤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
You may not qualify if:
- 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
- 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
- Pregnant or lactating women, or patients planning pregnancy within 90 days
- Renal failure or severe renal impairment (creatinine clearance \< 30 mL/min) at screening
- Liver function impairment: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal, or liver diseases (e.g., acute/chronic hepatitis, cirrhosis)
- Heart failure (NYHA Class III or IV), unstable angina, acute myocardial infarction, severe arrhythmia, or second/third-degree cardiac conduction obstruction within 6 months before randomization
- Drug abuse or addiction in the past year
- Concurrent malignant tumors or severe systemic diseases with an expected survival \< 90 days
- Severe mental disorders or dementia unable to complete the informed consent and follow-up
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
March 16, 2026
First Posted
March 19, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
June 18, 2028
Last Updated
March 30, 2026
Record last verified: 2026-03