Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06137300
• Other study ID #: TK-LAA
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, MD,PhD
• Phone: 13756661217
• Email: doctoryangyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 986
• Est. completion date: December 31, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years old;

2. Acute anterior circulation large artery atherosclerotic cerebral infarction (according to TOAST classification) within 48h of onset; NIHSS score =6, =15;

3. Moderate to severe stenosis or occlusion of offending vessels;

4. The mRS Score =2 before onset;

5. Subjects or their legal representatives agreed to the treatment and signed the informed consent form.

Exclusion Criteria:

1. Transient ischemic attack;

2. Patients who planned or had received emergency reperfusion therapy (including intravenous thrombolysis and emergency thrombectomy);

3. Severe disturbance of consciousness:GCS =8;

4. Patients who previously received angiotensin-converting enzyme inhibitor (ACEI) drugs regularly;

5. 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;

6. Liver dysfunction (ALT/AST >1.5 × upper limit of normal [ULN]), renal dysfunction (Cr >1 × ULN);

7. Coagulopathy (prolonged INR (>1.5) or prolonged APTT (>2 folds);

8. Cardioembolic stroke or high-risk factors of cardioembolic stroke identified by investigators (atrial fibrillation, cardiac mural thrombus, cardiomyopathy, etc.);

9. 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;

10. Unwilling to be followed up or poor treatment compliance;

11. Participating in other clinical investigators, or had participated in other clinical investigators within 3 months before enrollment;

12. Other conditions considered by the investigator to be inappropriate for enrollment.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Atherosclerosis
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Urinary kallidinogenase for injection
Urinary kallidinogenase 0.15PNA once daily for 7 days.

Other:
• Guideline-prescribed medical therapy
Guideline-prescribed medical therapy

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days	Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.	90 days
Secondary	National Institute of Health Stroke Scale (NIHSS) at 7days.	National Institute of Health stroke Scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.	7days
Secondary	Incidence of ischemic stroke within 90 days.	Including recurrent and new ischemic stroke.	0-90days
Secondary	Adverse events occurring in the course of the treatment.	Including all adverse events, severe adverse events and urinary kallidinogenase related adverse events.	0-7days