🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06085378
Starting soon Not applicable

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

NCT06085378 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Phase
Not applicable
Started
2024-01-01
Last updated
2023-10-16

Condition(s) studied

Acute Ischemic StrokeType 2 Diabetes

Investigational drug(s) / intervention(s)

Urinary Kallidinogenase for injectionPlacebo

Urinary Kallidinogenase for injection: 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

Placebo: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong

More First Affiliated Hospital, Sun Yat-Sen University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06085378 on ClinicalTrials.gov ↗ ← All trials in China