Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China

Study Overview
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Brief Summary
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To analyze the real situation of intravenous thrombolysis in acute ischemic stroke in China

Detailed Description
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Compare the efficacy and safety of different thrombolytic drugs; Analysis of patients during hospital treatment of adverse events and complications; Analysis of factors that affect the effectiveness of treatment; Evaluate the pharmacological benefits of different thrombolytic drugs

Official Title
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Intravenous ThrombolysisRegistry for Acute Ischemic Stroke in China

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: Alteplase
* Drug: Urokinase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) age> 18 years old; 2) meet the diagnostic criteria of China 2014 guidelines for the diagnosis and treatment of acute ischemic stroke; 3) no history of first sepsis or previous cerebral infarction sequelae (mRS ≤ 1); 4) within 3 hours of onset; 5) Have measurable neurological deficits; 6) Patients or legal guardians can understand and sign informed consent. Exclusion Criteria: Absolute exclusion criteria: 1) history of head trauma or stroke within the last 3 months; 2) suspected subarachnoid hemorrhage; 3) history of previous intracranial hemorrhage; 4) intracranial tumor, arteriovenous malformation or aneurysm ; 5) recent intracranial or intraspinal surgery; 6) arterial puncture at an incurable site within the last 7 days; 7) elevated blood pressure: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg; 8) Internal bleeding; 9) acute bleeding tendency, including platelet count less than 100 × 109 / L or other conditions; 10) heparin treatment within 48 h (APTT is outside the upper limit of normal range); 11) oral anticoagulant, INR> 1.7 Or PT> 15S; 12) are currently using thrombin inhibitors or factor Xa inhibitors, various sensitive laboratory abnormalities (such as APTT, INR, platelet count, ECT; TT or appropriate factor Xa activity assays) ; 13) Blood glucose <50 mg / dl (2.7 mmol / L); 14) CT suggestive of multiple cerebral infarction (low density range> 1/3 of the cerebral hemispheres) ; 15) Other conditions considered unsuitable for inclusion in this clinical study; 16) 3 months or are participating in other clinical trials; 17) combined with severe systemic disease is expected to survive less than three months. Relative exclusion criteria: 1) severe stroke (NIHSS> 25 points); 2) pregnancy; 3) neurological deficits after epileptic seizures; 4) major surgery or severe trauma within the last 14 days; 5) Urethral hemorrhage; 6) Myocardial infarction within the last 3 months;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alteplase group<br>According to 0.6-0.9mg / kg alteplase (maximum can not exceed 90mg), of which 10% intravenous injection, the remaining 60 minutes intravenous infusion | Drug: Alteplase<br>* According to 0.6-0.9mg / kg alteplase (maximum can not exceed 90mg), of which 10% intravenous injection, the remaining 60 minutes intravenous infusion.<br>|
| Urokinase group<br>1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously End | Drug: Urokinase<br>* 1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRS of 90 days after thrombolysis | Proportion of patients with mRS = 0-1 points 90 days after thrombolysis | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Adverse events | Symptomatic intracranial hemorrhage conversion rate; Liver and kidney dysfunction; Bleeding gums; Skin mucous membrane bleeding | Year 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alteplase; urokinase; intravenous thrombolysis