Ischemic stroke
Conditions
Interventions
Argatroban group:Clopidogrel 75 mg qd oral + Agatroban injection was pumped intravenously for 60 mg/d (day 1 and day 2) / 10mg bid (days 2-5)
after 7 days, clopidogrel 75 mg qd was used to 90 days
Control group:Clopidogrel 75mg qd +aspirin 100 mg qd oral ,clopidogrel 75 mg qd was used to 90 days
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) 18<= age < 80 years old, regardless of gender; (2) Clinical and imaging (CT and MRI) excluded cerebral hemorrhage or space occupying lesions; (3) 1) Acute cerebral infarction with onset time less than 72 hours and NIHSS score less than =5; 2) patients who did not receive intravenous thrombolysis or mechanical thrombectomy; (4) No obvious sequelae of the first attack or previous stroke (mRS<=1); (5) Understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) coma (patients with NIHSS 1a consciousness level item >1); 2) severe stroke symptoms (NIHSS>10); 3) pseudobulbar palsy with dysphagia; 4) intracranial hemorrhagic diseases detected by head CT: cerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural or epidural hematoma; 5) previous history of cerebral hemorrhage, subarachnoid hemorrhage, cerebral arteriovenous malformation or aneurysm, or brain tumor; 6) The following serious medical complications: refractory hypertension, persistently higher than 200/110 MMHG; Severe liver disease (ALT or AST>2 times the upper limit of normal, or total bilirubin >20mmol/L, or acute hepatitis, chronic active hepatitis, or cirrhosis); Severe renal disease (renal insufficiency, defined as creatinine clearance 2.0mg/dl or >177µmol/L); Difficult to control diabetes (random blood glucose >15mol/L at enrollment despite clinical control with oral drugs or insulin therapy, or clinical diagnosis of diabetic ketoacidosis or hyperosmolar coma); Congestive heart failure; Malignant tumors; Other serious organ diseases; Gastrointestinal disorders that seriously affect drug absorption; 7) presence of contraindications to argatroban, clopidogrel or aspirin, including allergy, severe renal or hepatic insufficiency, history of thrombocytopenia or platelet count < 100x10^9/L, history of coagulopathy or systemic bleeding; 8) taking OAC or requiring OAC during the study; 9) gastrointestinal bleeding, urinary tract bleeding, or major surgery in the past 3 months; 10) pregnant or lactating women, those planning to become pregnant throughout the trial, and menstruating women; 11) unable to cooperate due to psychiatric symptoms; 12) have participated in or are currently participating in another clinical trial within 30 days before the date of informed consent;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90-day mRS 0-1 ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Compliance of cardiovascular and cerebrovascular events in 90 days;mRS: Proportion of patients with a score of 0-2;EQ-VAS scale score at 90 days;BI score at 90 days;The proportion of early neurological improvement at 48 hours (NIHSS score decreased by 2 points);;The proportion of early neurological deterioration at 48 hours (NIHSS score increased by 4 points);Incidence of adverse events;;Deaths within 90 days; | — |
Countries
China
Contacts
Public ContactHuiting Zhang
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed