Acute ischemic stroke with type 2 diabetes mellitus
Conditions
Interventions
Experimental group:The 0.15PNA 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 inc
Control group:The 0.15PNA 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
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years old and =80 years old; 2. Patients with acute ischemic stroke diagnosed with complete anterior circulation infarction (TACI) and partial anterior circulation infarction (PACI) according to OCSP classification criteria, see Appendix 6; 3. 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; 4. 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"; 5. First onset or previous history of cerebral infarction but mRS=1 score before onset; 6.6 = NIHSS = 20; 7. Prior to the start of the trial, the patient and/or his legal representative voluntarily signed an informed consent approved by the Ethics Committee;
Exclusion criteria
Exclusion criteria: 1. Acute intracranial hemorrhagic diseases confirmed by imaging: parenchymal hemorrhage, epidural hematoma, subdural hematoma, ventricle hemorrhage, subarachnoid hemorrhage, etc. 2. Patients who are ready to undergo or have undergone intravascular interventional therapy after the onset of the disease; 3. Patients who are ready to undergo or have undergone intravenous thrombolytic therapy after the onset of the disease; 4. Severe disturbance of consciousness: NIHSS 1a consciousness level score =2 points; 5. Patients with fracture, claudication and other factors affecting functional outcome score upon admission; 6. After the onset of the disease, Edaravone injection, Edaravone dextrocamphorol injection concentrated solution, butylphthalein sodium chloride injection or butylphthalein softgel capsule have been used; 7. Chinese patent medicine injection for improving cerebral blood circulation has been applied after the onset of this disease (see 8.4.2 for details); 8. Patients with hypotension (blood pressure less than 90/60mmHg) upon admission; 9. Have a history of severe food or drug allergy, or have been allergic to or intolerant of Eurecline injection; 10. Eurecline for injection has used ACEI drugs before taking the drug and has not exceeded 5 half-lives (according to the specific drug instructions); 11. Patients who are pregnant or breastfeeding and who plan to become pregnant within 90 days; 12. Renal failure or severe renal impairment at the time of screening (creatinine clearance 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.; 14. 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; 15. Those who met 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); 16. Persons who have abused or become addicted to drugs (narcotics, drugs) in the past year; 17. Patients with malignant tumors or severe systemic diseases with an expected survival of less than 90 days; 18. Patients with serious mental disorders or dementia who cannot cooperate to complete informed consent and follow-up; 19. Participated in any interventional drug or device clinical trials within 3 months prior to screening; 20. Patients deemed unsuitable for study participation by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with mRS 0-2 scores at 90±7 days after stroke; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with mRS 0-3 scores at 90±7 days after stroke;Orderly distribution of mRS On 90±7 days after stroke;Changes in NIHSS compared with baseline on day 10 of treatment;Changes of Barthel index at 90±7 days after stroke compared with baseline;Changes in MMSE from baseline at 90±7 days after stroke;Changes in MoCA from baseline at 90±7 days after stroke; | — |
Countries
China
Contacts
Public ContactJinseng Zeng
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed