Acute Ischemic Stroke
Conditions
Interventions
Intervention Group:In addition to the first use of 100 units (1 unit), after 1 daily use, each time with 300 units (3), added to 250 ml of 0.9% sodium chloride injection or 5% glucose injection dilute
Control group:Placebo
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 85 years; 2. Acute ischemic stroke (WHO diagnostic criteria); 3. 2 points of MSRS <= onset; 4. Moderate to severe ischemic stroke patients, NIHSS score 4-25 points; 5. Clinical first onset, unsolved thrombosis or in-vascular treatment; 6. Research drugs may be applied within 72 hours of the onctication of symptoms; 7. Both the patient and his or her legal representative are able and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Intracranial hemorrhage (cerebral hemorrhage, subcranial hemorrhage, epidural/subdural bleeding, etc.); 2. intracranial tumors, aneurysms; 3. A history of severe head trauma or stroke in the last three months; 4. A history of intracranial or intravertebral surgery in the last 3 months; Drugs affecting the formation of fibrinogen and thrombotic fibrin, such as other fibrous drugs or snake venom preparations, have been used within 1 week of E.1; drugs that have taken or require oral anticoagulants and INR>1.7 or PT>15s; and require double antiplate platelite therapy; 5. Acute bleeding tendency, presence of clotting disorders, including plate count less than 100 x 109 or other diseases; 6. Aortic bow mezzanine; 7. The drug in this study tested positive; 8. Patients with severe liver and kidney insexuality, active tuberculosis holes and peptic ulcers; (severe liver insanity is defined as ALT > 3 times normal upper limit or AST>2 times normal upper limit; severe renal insanity is defined as creatinine >2 times normal upper limit); 9. Treated blood = 200/110mmHg; 10. Severe consciousness disorder, GCS <= 8 points; 11. Women who have tested positive for pregnancy, are pregnant or lactating; 12. Participated in other drug or instrument trials within 30 days of randomization; 13. Due to mental disorders, cognitive or emotional impairments are not understood and/or subject to research procedures and/or follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-month mRS score after taking the drug;Bleeding events during medication defined by PLATO; | — |
Secondary
| Measure | Time frame |
|---|---|
| The ratio of mRS scores of 0-2 in 30-day and 3-month;NIHSS score in 8-day, 30-day, 3-month after taking drug;SS-QOL score, EQ-5D-3 score, and Barthel index in 8-day, 30-day, 3-month after taking drug;Recurrence of acute ischemic stroke in 30-day and 90-day after taking drug;NIHSS score increased >=4 points during drug use;Venous thrombosis in the lower extremities occurence during drug use;Fibrinogen, D-dimer, and TpP variation;Bleeding events defined by PLATO in 30-day and 3-month after drug application;Drug-related adverse events (elevated transaminase, allergic reactions, asthma, etc.) during medication;Death during medication, including all-cause, isobleed vascular and hemorrhagic vascular death;Death in 3-month after drug application, including all-cause, isobleed vascular and hemorrhagic vascular death; | — |
Countries
China
Contacts
Public ContactLi He
West China Hospital, Sichuan University
Outcome results
None listed