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

February 25, 2024 updated by: Yi Yang

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

986

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zhenni Guo, MD,PhD
  • Phone Number: 0086 18186872986
  • Email: zhen1ni2@163.com

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130000
        • First Hospital of Jilin University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Urinary Kallidinogenase group
Patients are treated with urinary kallidinogenase and guideline-prescribed basic medical therapy.
Drug: Urinary kallidinogenase for injection
Urinary kallidinogenase 0.15PNA once daily for 7 days.
Other Names:
  • Guideline-prescribed medical therapy
Other: Control group
Patients are only treated with guideline-prescribed basic medical therapy.
Other: Guideline-prescribed medical therapy
Guideline-prescribed medical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
Time Frame: 90 days
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institute of Health Stroke Scale (NIHSS) at 7days.
Time Frame: 7days
National Institute of Health stroke Scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.
7days
Incidence of ischemic stroke within 90 days.
Time Frame: 0-90days
Including recurrent and new ischemic stroke.
0-90days
Adverse events occurring in the course of the treatment.
Time Frame: 0-7days
Including all adverse events, severe adverse events and urinary kallidinogenase related adverse events.
0-7days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yi Yang

Investigators

  • Principal Investigator: Yi Yang, MD,PhD, The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 14, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TK-LAA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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