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

NCT06085378 | Not Yet Recruiting

• 1 other identifier: IIT-2023-509
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

  90±7 days

Secondary Outcomes (6)

• The proportion of patients with modified rankin scale (mRS) 0-3 scores at 90±7 days

  90±7 days

• Distribution of modified rankin scale (mRS) at 90±7 days

  90±7 days

• Changes of NIHSS from baseline to 10 days

  from baseline to day 10

• Changes of Barthel index from baseline to 90±7 days

  from baseline to day 90±7

• Changes of mini-mental state examination (MMSE) from baseline to 90±7 days

  from baseline to day 90±7

Other Outcomes (6)

• Changes of fasting blood glucose values from baseline to 10 days

  from baseline to day 10

• Changes of HBA1c from baseline to 90±7 days

  from baseline to day 90±7

• Changes of hypersensitive C-reactive protein (hs-CRP) and interleukin-6 (IL-6)

  from baseline to day 10

Study Arms (2)

Urinary Kallidinogenase for injection

EXPERIMENTAL

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

Drug: Urinary Kallidinogenase for injection

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Urinary Kallidinogenase for injection DRUG

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

Also known as: KLK、HUK

Urinary Kallidinogenase for injection

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ≤NIHSS≤20;
• Have provided signed written informed consent from the patient or the patient's legal representative

You may not qualify if:

• 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);

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Ischemic Stroke; Diabetes Mellitus, Type 2

Interventions

Injections

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jinsheng Zeng

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinsheng Zeng

CONTACT

+8613322800657; zengjs@pub.guangzhou.gd.cn

Jian Zhang

CONTACT

+8613560451639; zhjian55@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: October 16, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

CN (1)