Acute Ischemic Stroke
Conditions
Interventions
experimental group:Lumbrokinase Enteric-Coated Capsules (once a pill (600,000 units), three times a day, take orally half an hour before meal), plus aspirin enteric-coated tablets (once 100mg, once a
control group:placebo of Lumbrokinase Enteric-Coated Capsules (once a pill, three times a day, take orally half an hour before meal) plus aspirin enteric-coated tablets (once 100mg, once a day, take o
Sponsors
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
35 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Participant is diagnosed with acute ischemic stroke for the first time; 2.Symptoms of acute ischemic stroke appear within 72 hours; 3.Before the onset of symptoms of acute ischemic stroke, the mRS score of the participant is less than or equal to 2; 4.Participants are not candidates for intravenous thrombolysis, arterial thrombolysis or intravascular interventional therapy upon assessment; 5.The participant's NIHSS score is greater than 5 and less than 15; 6.The age of the participant is between 35 and 85 years old; 7.Agree to participate in the trial and signed informed consent form.
Exclusion criteria
Exclusion criteria: 1.The participant has a hemorrhagic cerebrovascular disease (including subarachnoid hemorrhage, cerebral hemorrhage, and other intracranial hemorrhage); 2.Transient ischaemic attack (TIA) and silent cerebral infarction; 3.Known or suspicion for cardiogenic embolism: atrial fibrillation, dilated cardiomyopathy, infective endocarditis, mitral valve prolapse, sick sinus syndrome, atrial myxoma, patent foramen ovale, atrial septal defect, ventricular wall aneurysm, etc; 4.Carotid artery stenosis >= 70%; 5.Blood pressure exceeds 180/100mmHg (24/13.3kPa) after active drug treatment; 6.Blood homocysteine exceeds 20µ mol/L after active drug treatment; 7.Used defibrase within 24 hours (including urokinase, snake venom preparation, batroxobin, lumbrokinase, etc.); 8.Have the following serious complications: (1) Cardiac insufficiency: myocardial infarction, acute heart failure; (2) Hepatic insufficiency: total bilirubin > 3mg/dL, albumin =120IU/mL); (3) Renal insufficiency: creatinine > 178 umol/L(2mg/dL), urea nitroge > 18mmol/L (40mg/dL); 9.Participant with bleeding tendencies (active gastric ulcers or bleeding) or hemorrhagic diseases or severe bleeding within 3 months, such as hemoptysis, hematochezia (fecal occult blood test), thrombocytopenic purpura, coagulopathy with INR>1.7, active tuberculosis, etc., including platelet count< 100 x 10^9/L; 10.Participant already on anticoagulants or antiplatelet drugs or take nonsteroidal anti-inflammatory drugs within 7 days prior to the stroke event; 11.Participant is allergic or intolerant to lumbrokinase?or aspirin; 12.Participant with dysphagia and could not be given drugs orally; 13.Participant with a history of malignant tumor or aneurysm (including intracranial aneurysm or peripheral aneurysm); 14.Women with recent pregnancy plans, as well as pregnant and lactating women; 15.Participant who has had surgery in the last 7 days; 16.Participant has a major mental illness, and couldnt control their own actions, unable to cooperate with the trial; 17.Participant who is unable to understand the informed consent form or is unwilling to provide personal information or does not want to enter the trial; 18.Participant who participated in another clinical trial in the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale score (mRS); | — |
Secondary
| Measure | Time frame |
|---|---|
| National Institutes of Health Stroke Scale (NIHSS);Activity of Daily Living (ADL) Scale score (Barthel index);prothrombin time (PT);activated partial thromboplastin time (APTT);fibrinogen (FIB);Platelet aggregation rate;Hypersensitive C-reactive protein (hs-CRP); | — |
Countries
China
Contacts
Public ContactHongcai Shang/ Baolin Yang
Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
Outcome results
None listed