Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Urinary kallidinogenase for injection, Guideline-prescribed medical therapy.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke：a Multicentre, Prospective, Randomised, Open-label, Blinded-Endpoint Trial
Overview
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.
Detailed description
Currently, evidence regarding the safety and efficacy of urinary kallidinogenase treatment in patients with acute ischemic stroke lacks, and few of related studies were large-scale and high-quality. Thus, this study was designed to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.
Interventions
- Drug Urinary kallidinogenase for injection
Urinary kallidinogenase 0.15PNA once daily for 7 days. - Other Guideline-prescribed medical therapy
Guideline-prescribed medical therapy
Primary outcome measures
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days [Time frame: 90 days]
Secondary outcome measures (3)
- National Institute of Health Stroke Scale (NIHSS) at 7days. [Time frame: 7days]
- Incidence of ischemic stroke within 90 days. [Time frame: 0-90days]
- Adverse events occurring in the course of the treatment. [Time frame: 0-7days]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Transient ischemic attack;
- Patients who planned or had received emergency reperfusion therapy (including intravenous thrombolysis and emergency thrombectomy);
- Severe disturbance of consciousness:GCS ≤8;
- Patients who previously received angiotensin-converting enzyme inhibitor (ACEI) drugs regularly;
- 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;
- 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);
- Cardioembolic stroke or high-risk factors of cardioembolic stroke identified by investigators (atrial fibrillation, cardiac mural thrombus, cardiomyopathy, etc.);
- 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;
- Participating in other clinical investigators, or had participated in other clinical investigators within 3 months before enrollment;
- Other conditions considered by the investigator to be inappropriate for enrollment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- First Hospital of Jilin University — Changchun
Identifiers
NCT: NCT06137300 · TK-LAA