search
Back to results

Efficacy and Safety of Urinary Kallidinogenase in the Treatment of Acute Ischemic Stroke Combined With Type 2 Diabetes Mellitus (TK-SEEK)

Primary Purpose

Acute Ischemic Stroke, Type 2 Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Urinary Kallidinogenase for injection
Placebo
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years old and ≤80 years old; Patients with acute ischemic stroke diagnosed with complete anterior circulation infarction (TACI) and partial anterior circulation infarction (PACI) according to Oxfordshire Community Stroke Project classification (OCSP), see Appendix 6; Refer to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition), have been diagnosed with type 2 diabetes (need to have a medical history to confirm), see Appendix 7; The time from the occurrence of the stroke to the time of admission is less than 48h. If the exact time of onset is unknown, the time of onset of the patient is defined as "the time that finally seems normal"; First-ever ischemic stroke or have history of ischemic stroke but mRS≤1 before onset; 6≤NIHSS≤20; Have provided signed written informed consent from the patient or the patient's legal representative Exclusion Criteria: Acute intracranial hemorrhagic diseases confirmed by imaging: parenchymal hemorrhage, epidural hematoma, subdural hematoma, ventricle hemorrhage, subarachnoid hemorrhage, etc. Patients who are ready to undergo or have undergone intravascular interventional therapy after the onset of the disease; Patients who are ready to undergo or have undergone intravenous thrombolytic therapy after the onset of the disease; Severe disturbance of consciousness: NIHSS 1a consciousness level score ≥2; Patients with fracture, claudication and other factors affecting functional outcome score upon admission; After the onset of the disease, Edaravone injection, Edaravone and Dexborneol concentrated solution for injection, Butylphthalide and sodium chloride injection or Butylphthalide soft capsules have been used; Chinese patent medicine injection for improving cerebral blood circulation has been applied after the onset of this disease (see 8.4.2 for details); Patients with hypotension (blood pressure less than 90/60mmHg) upon admission; Have a history of severe food or drug allergy, or have been allergic to or intolerant of Eurecline injection; Eurecline for injection has used angiotensin-converting enzyme inhibitor (ACEI) drugs before taking the drug and has not exceeded 5 half-lives (according to the specific drug instructions); Patients who are pregnant or breastfeeding and who plan to become pregnant within 90 days; Renal failure or severe renal impairment at the time of screening (creatinine clearance < 30ml/min); Liver function impairment: alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2.5 times the upper limit of normal, or other known serious liver diseases such as active infection of acute and chronic hepatitis, cirrhosis, etc.; Patients with heart failure (NYHA class III or IV), unstable angina pectoris, acute myocardial infarction, severe arrhythmia, and degree II and III cardiac conduction obstruction within 6 months prior to randomization; Those who meet the heavy drinking standard in the three months before the screening period, that is, drinking ≥5 standard drinks per day (1 standard drink is equivalent to 120ml wine, 360ml beer or 45ml liquor); Patients who have abused or become addicted to drugs (narcotics, drugs) in the past year; Patients with malignant tumors or severe systemic diseases with an expected survival of less than 90 days; Patients with serious mental disorders or dementia who cannot cooperate to complete informed consent and follow-up; Participated in any interventional drug or device clinical trials within 3 months prior to screening; Patients deemed unsuitable for study participation by the investigator;

Sites / Locations

  • The First Affiliated Hospital, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Urinary Kallidinogenase for injection

Placebo

Arm Description

Patients in this arm will be given urinary kallidinogenase for injection, 0.15 peptide nucleic acids(PNA), once a day for 10 days

An inactive substance identical in appearance to the urinary kallidinogenase for injection, once a day for 10 days

Outcomes

Primary Outcome Measures

The proportion of patients with modified rankin scale (mRS) 0-2 scores at 90±7 days
The proportion of patients with modified rankin scale (mRS) 0-2 scores at 90±7 days

Secondary Outcome Measures

The proportion of patients with modified rankin scale (mRS) 0-3 scores at 90±7 days
The proportion of patients with modified rankin scale (mRS) 0-3 scores at 90±7 days
Distribution of modified rankin scale (mRS) at 90±7 days
Distribution of modified rankin scale (mRS) at 90±7 days
Changes of NIHSS from baseline to 10 days
Changes of NIHSS from baseline to 10 days
Changes of Barthel index from baseline to 90±7 days
Changes of Barthel index from baseline to 90±7 days
Changes of mini-mental state examination (MMSE) from baseline to 90±7 days
Changes of mini-mental state examination (MMSE) from baseline to 90±7 days
Changes of Montreal cognitive assessment (MoCA) from baseline to 90±7 days
Changes of Montreal cognitive assessment (MoCA) from baseline to 90±7 days

Full Information

First Posted
September 7, 2023
Last Updated
October 13, 2023
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT06085378
Brief Title
Efficacy and Safety of Urinary Kallidinogenase in the Treatment of Acute Ischemic Stroke Combined With Type 2 Diabetes Mellitus
Acronym
TK-SEEK
Official Title
Efficacy and Safety of Urinary Kallidinogenase in the Treatment of Acute Ischemic Stroke Combined With Type 2 Diabetes Mellitus (TK-SEEK): a Prospective, Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is a multicenter, randomized, double-blind, placebo parallel control study, aim to evaluate the efficacy and safety of human urinary kallidinogenase in the treatment of acute ischemic stroke with type 2 diabetes.
Detailed Description
The study process lasts for a total of 90 days, including the screening period, intervention period, and follow-up period. During the intervention period, the experimental group is treated with Urinary Kallidinogenase, while the control group is treated with placebo for 10 days. Both groups receive routine clinical treatment. All patients are followed up until the 90th day after stroke. The sample size of the study is 630 patients. The ratio of the experimental group to the control group is 1:1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke, Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
630 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Urinary Kallidinogenase for injection
Arm Type
Experimental
Arm Description
Patients in this arm will be given urinary kallidinogenase for injection, 0.15 peptide nucleic acids(PNA), once a day for 10 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
An inactive substance identical in appearance to the urinary kallidinogenase for injection, once a day for 10 days
Intervention Type
Drug
Intervention Name(s)
Urinary Kallidinogenase for injection
Other Intervention Name(s)
KLK、HUK
Intervention Description
The 0.15 peptide nucleic acids(PNA) unit of Eurecrine for injection was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day. The solvent can be increased and/or slowed down according to the patient's condition for 10 consecutive days, while receiving clinical routine treatment for 10 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The 0.15 peptide nucleic acids(PNA) unit of placebo was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day. The solvent can be increased and/or slowed down according to the patient's condition for 10 consecutive days, while receiving clinical routine treatment for 10 days.
Primary Outcome Measure Information:
Title
The proportion of patients with modified rankin scale (mRS) 0-2 scores at 90±7 days
Description
The proportion of patients with modified rankin scale (mRS) 0-2 scores at 90±7 days
Time Frame
90±7 days
Secondary Outcome Measure Information:
Title
The proportion of patients with modified rankin scale (mRS) 0-3 scores at 90±7 days
Description
The proportion of patients with modified rankin scale (mRS) 0-3 scores at 90±7 days
Time Frame
90±7 days
Title
Distribution of modified rankin scale (mRS) at 90±7 days
Description
Distribution of modified rankin scale (mRS) at 90±7 days
Time Frame
90±7 days
Title
Changes of NIHSS from baseline to 10 days
Description
Changes of NIHSS from baseline to 10 days
Time Frame
from baseline to day 10
Title
Changes of Barthel index from baseline to 90±7 days
Description
Changes of Barthel index from baseline to 90±7 days
Time Frame
from baseline to day 90±7
Title
Changes of mini-mental state examination (MMSE) from baseline to 90±7 days
Description
Changes of mini-mental state examination (MMSE) from baseline to 90±7 days
Time Frame
from baseline to day 90±7
Title
Changes of Montreal cognitive assessment (MoCA) from baseline to 90±7 days
Description
Changes of Montreal cognitive assessment (MoCA) from baseline to 90±7 days
Time Frame
from baseline to day 90±7
Other Pre-specified Outcome Measures:
Title
Changes of fasting blood glucose values from baseline to 10 days
Description
Changes of fasting blood glucose values from baseline to 10 days
Time Frame
from baseline to day 10
Title
Changes of HBA1c from baseline to 90±7 days
Description
Changes of HBA1c from baseline to 90±7 days
Time Frame
from baseline to day 90±7
Title
Changes of hypersensitive C-reactive protein (hs-CRP) and interleukin-6 (IL-6)
Description
Changes of hypersensitive C-reactive protein (hs-CRP) and interleukin-6 (IL-6)
Time Frame
from baseline to day 10
Title
Changes of urea nitrogen, creatinine and urinary protein
Description
Changes of urea nitrogen, creatinine and urinary protein
Time Frame
from baseline to day 10
Title
Stroke recurrence rate within 90 days
Description
Stroke recurrence rate within 90 days
Time Frame
90 days
Title
Incidence, severity, and causality of adverse events (AE) and serious adverse events (SAE) during the intervention
Description
Incidence, severity, and causality of adverse events (AE) and serious adverse events (SAE) during the intervention
Time Frame
during the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old and ≤80 years old; Patients with acute ischemic stroke diagnosed with complete anterior circulation infarction (TACI) and partial anterior circulation infarction (PACI) according to Oxfordshire Community Stroke Project classification (OCSP), see Appendix 6; Refer to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition), have been diagnosed with type 2 diabetes (need to have a medical history to confirm), see Appendix 7; The time from the occurrence of the stroke to the time of admission is less than 48h. If the exact time of onset is unknown, the time of onset of the patient is defined as "the time that finally seems normal"; First-ever ischemic stroke or have history of ischemic stroke but mRS≤1 before onset; 6≤NIHSS≤20; Have provided signed written informed consent from the patient or the patient's legal representative Exclusion Criteria: Acute intracranial hemorrhagic diseases confirmed by imaging: parenchymal hemorrhage, epidural hematoma, subdural hematoma, ventricle hemorrhage, subarachnoid hemorrhage, etc. Patients who are ready to undergo or have undergone intravascular interventional therapy after the onset of the disease; Patients who are ready to undergo or have undergone intravenous thrombolytic therapy after the onset of the disease; Severe disturbance of consciousness: NIHSS 1a consciousness level score ≥2; Patients with fracture, claudication and other factors affecting functional outcome score upon admission; After the onset of the disease, Edaravone injection, Edaravone and Dexborneol concentrated solution for injection, Butylphthalide and sodium chloride injection or Butylphthalide soft capsules have been used; Chinese patent medicine injection for improving cerebral blood circulation has been applied after the onset of this disease (see 8.4.2 for details); Patients with hypotension (blood pressure less than 90/60mmHg) upon admission; Have a history of severe food or drug allergy, or have been allergic to or intolerant of Eurecline injection; Eurecline for injection has used angiotensin-converting enzyme inhibitor (ACEI) drugs before taking the drug and has not exceeded 5 half-lives (according to the specific drug instructions); Patients who are pregnant or breastfeeding and who plan to become pregnant within 90 days; Renal failure or severe renal impairment at the time of screening (creatinine clearance < 30ml/min); Liver function impairment: alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2.5 times the upper limit of normal, or other known serious liver diseases such as active infection of acute and chronic hepatitis, cirrhosis, etc.; Patients with heart failure (NYHA class III or IV), unstable angina pectoris, acute myocardial infarction, severe arrhythmia, and degree II and III cardiac conduction obstruction within 6 months prior to randomization; Those who meet the heavy drinking standard in the three months before the screening period, that is, drinking ≥5 standard drinks per day (1 standard drink is equivalent to 120ml wine, 360ml beer or 45ml liquor); Patients who have abused or become addicted to drugs (narcotics, drugs) in the past year; Patients with malignant tumors or severe systemic diseases with an expected survival of less than 90 days; Patients with serious mental disorders or dementia who cannot cooperate to complete informed consent and follow-up; Participated in any interventional drug or device clinical trials within 3 months prior to screening; Patients deemed unsuitable for study participation by the investigator;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinsheng Zeng
Phone
+8613322800657
Email
zengjs@pub.guangzhou.gd.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Zhang
Phone
+8613560451639
Email
zhjian55@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinsheng Zeng
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinsheng Zeng
Phone
+8613322800657
Email
zengjs@pub.guangzhou.gd.cn
First Name & Middle Initial & Last Name & Degree
Jian Zhang
Phone
+8613560451639
Email
zhjian55@mail.sysu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Urinary Kallidinogenase in the Treatment of Acute Ischemic Stroke Combined With Type 2 Diabetes Mellitus

We'll reach out to this number within 24 hrs