Used for improving the neurological symptoms, activities of daily living and dysfunction caused by acute thrombotic cerebral infarction
Conditions
Interventions
Piragrel Sodium Injection Test Group:2 vials/time, diluted in 250 ml normal saline and intravenously infused at 3 ± 0.5 h. The interval from the start of the previous administration to the start of th
Control group of sodium chloride injection:2 vials/time, diluted in 250 ml normal saline and intravenously infused at 3 ± 0.5 h. The interval from the start of the previous administration to the start
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed as acute ischemic stroke according to Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke (2018); 2. 35 - 80 years old, regardless of gender; 3. Be able to initiate study treatment within 48 hours of stroke onset; * If occurs during sleep, the time of last normal appearance. should be used as the time of onset; 4. After the onset of this stroke, the NIHSS score was 5-22 points; 5. The First-time stroke or previous history of stroke without significant neurological impairment (mRS Score <= 1 before the onset of this stroke); 6. Fertile men and women of childbearing age have no childbearing planning and are willing to take effective contraceptive measures from signing the informed consent form to 6 months after administration; 7. The patient or his legal representative fully understands and voluntarily signs the informed consent form which approved by the Ethics Committee.
Exclusion criteria
Exclusion criteria: 1. Suspected comorbidity intracranial bleeding disorders or space-occupying disease, including: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, intracranial tumor or intracranial aneurysm, etc.; 2. Suspected ischemic stroke due to cardiogenic cerebral embolism or other causes, such as moyamoya disease, cerebral artery dissection or associated aortic arch dissection, etc.; 3. Cranial CT scan finds that the middle cerebral artery infarct area is over 1/3; 4. Judged by clinicians as a transient ischemic attack (TIA); 5. Severe consciousness disturbance: NIHSS 1a consciousness level > 1 point; 6. Severe hypertension: Systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 110 mmHg after medication control; 7. Severe blood glucose abnormalities: Blood glucose 22.22 mmol/L; 8. There are abnormalities in the following clinical laboratory tests: (1) Blood routine: Platelet count 1.5 or Activated Partial Thromboplastin Time (APTT) > 1.5×ULN; (3) Alanine aminotransferase or aspartate aminotransferase > 2.0×ULN; (4) Creatinine > 1.5×ULN; 9. Have suffered from hemorrhagic disease: history of cerebral hemorrhage, history of important bleeding in other organs, such as history of clinically significant gastrointestinal or urinary bleeding within the past 3 months, etc.; 10. Patients with history of severe mental disorders, dementia, epilepsy, or epileptic seizures; 11. Have serious heart disease, including but not limited to: (1) Atrial fibrillation (history included), including persistent or paroxysmal atrial fibrillation; (2) Severe arrhythmias, including degree II and III atrioventricular blocks, resting heart rate 120 times/min; (3) Clinically significant Class III or IV (NYHA) congestive heart failure or a history of end-stage cardiovascular disease; (4) History of unstable angina pectoris or acute myocardial infarction within the past 3 months; 12. Had claudication, severe arthritis or severe neurological disability left over from previous diseases, and could not independently engage in activities of daily living before the onset of this stroke; 13. Patients with a history of malignant tumors (except cured basal cell carcinoma of skin or carcinoma in situ of cervix) within the past 5 years or undergoing antitumor treatment; 14. Patients with other severe systemic disease, life expectancy is less than 90 days; 15. Patients who received or plan to accept intravenous thrombolytic therapy after the onset of this stroke; 16. Patients who received or plan to accept intravascular treatment after the onset of this stroke; 17. Patients who received or plan to accept anticoagulants, or fiber-lowering, or triple antiplatelet therapy; 18. Patients who used or plan to accept other drugs with neuroprotective effects as stated in the instructions (including Traditional Chinese medicine); 19. It is known to be allergic or intolerance to investigational drug (including excipients) drugs or materials to be used for basic treatment (antiplatelet therapy) or imaging examination; 20. Have history of alcohol abuse, drug abuse and/or drug dependence; 21. Pregnant or beastfeeding women; 22. Have received other investigational drugs/devices within the past 3 months, or be participating in other clinical studies; 23. The investigator believes that the patient is not suitable for t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary indicator; | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary indicator;Secondary indicator;Secondary indicator;Secondary indicator;Secondary indicator;Secondary indicator; | — |
Countries
China
Contacts
Public ContactWang Yongjun
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed