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

NCT06137300 | Not Yet Recruiting DMC

• 1 other identifier: TK-LAA
• Study Type: interventional
• Target: 986
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke, Urinary Kallidinogenase

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• National Institute of Health Stroke Scale (NIHSS) at 7days.

  7days

• Incidence of ischemic stroke within 90 days.

  0-90days

• Adverse events occurring in the course of the treatment.

  0-7days

Study Arms (2)

Urinary Kallidinogenase group

EXPERIMENTAL

Patients are treated with urinary kallidinogenase and guideline-prescribed basic medical therapy.

Drug: Urinary kallidinogenase for injection

Control group

OTHER

Patients are only treated with guideline-prescribed basic medical therapy.

Other: Guideline-prescribed medical therapy

Interventions

Urinary kallidinogenase for injection DRUG

Urinary kallidinogenase 0.15PNA once daily for 7 days.

Also known as: Guideline-prescribed medical therapy

Urinary Kallidinogenase group

Guideline-prescribed medical therapy OTHER

Guideline-prescribed medical therapy

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Injections

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yi Yang, MD,PhD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Yang, MD,PhD

CONTACT

13756661217; doctoryangyi@163.com

Zhenni Guo, MD,PhD

CONTACT

18186872986; zhen1ni2@163.com

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: SPONSOR INVESTIGATOR
• PI Title: Associated Dean of the First Hospital of Jilin University

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: March 15, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CN (1)