Intravenous Thrombolysis Registry for Chinese Ischemic Stroke Within 4.5 h Onset

Study Overview
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Brief Summary
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Stroke is one of the leading causes of death and disability in China. Intravenous thrombolysis with recombinant tissue plasminogen activator (rtPA) improves the outcome for ischemic stroke patients who can be treated within 4.5 hours of symptom onset. In China, in addition to rt-PA, intravenous urokinase within 6 h has also been recommended by the 2010 Chinese Guidelines for the Diagnosis and Treatment of Patients with Acute Ischemic Stroke, and supported by evidence from two intravenous urokinase thrombolysis trials. Urokinase is used more frequently than rt-PA, mainly because it is cheaper. To describe Chinese experience with thrombolytic therapy for Ischemic Stroke within 4.5h onset, we designed a multicenter, prospective, registry study. The aim of INtravenous Thrombolysis REgistry for Chinese Ischemic Stroke within 4.5 h onset（INTRECIS）was to assess the safety and efficacy of intravenous rtPA, urokinase as thrombolytic therapy within the first 4.5 h of onset of acute ischaemic stroke.

Detailed Description
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INTRECIS is a prospective multicenter registry using data from 60 centres in the North China. Consecutive patients with acute ischemic stroke who are treated with intravenous rtPA, urokinase within 4.5 hours of symptom onset in 60 centres of the North China will be eligible for this registry. Patient involvement in the registry shall not influence any treatment decision. Patients will undergo a complete diagnostic work up including a clinical neurological examination using the National Institutes of Health Stroke Scale (NIHSS) score, laboratory examination, brain and neurovascular imaging, echocardiography, 24-hours ECG. Clinical outcome will be evaluated on day 1 and day 14 using the National Institute of Health Stroke Scale (NIHSS) score, evaluated at 3 months using modified Rankin Scale score (mRS) and assessing adverse events. The proportion of patients with excellent outcome (mRS 0 to 1) at 3 months after treatment will serve as the primary outcome. Secondary outcome measures will include independent functional outcome (mRS 0 to 2), changes in NIHSS at 1 and 14 day compared with baseline, symptomatic intracerebral haemorrhage, recurrent stroke and all-cause mortality.

Official Title
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Intravenous Thrombolysis Registry for Chinese Ischemic Stroke Within 4.5 h Onset

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: rtPA
* Drug: urokinase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years ischemic stroke diagnosed by CT or MRI first stroke onset or past stroke without obvious neurological deficit (mRS≤1) Time from onset to treatment: ≤ 4.5 hours Treatment with intravenous rtPA or urokinase Signed informed consent by patient self or legally authorized representatives Exclusion Criteria: History of subarachnoid hemorrhage, intracranial hemorrhage and hemorrhagic cerebral infarction Obvious head injuries or strokes within 3 months Intracranial tumor, arteriovenous malformation or aneurysm Intracranial or spinal cord surgery within 3 months Gastrointestinal or urinary tract hemorrhage within the previous 21 days Blood glucose < 50 mg/dl (2.7mmol/L) Heparin therapy or oral anticoagulation therapy within 48 hours Oral warfarin is being taken and INR>1.6 Severe systemic disease which is expected to survive less than 3 months Major surgery within 1 month Uncontrolled hypertension (>180/100 mmHg) Platelet count < 10×109／L Patients who have been involved in other clinical trials within 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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rtPA<br>Intravenous rt-PA thrombolysis shall be administered within 4.5 h after symptom onset, at a dose of 0.9 mg/kg body weight (maximum, 90 mg), with 10% of the dose given as a bolus over 1 min and the remaining 90% infused over 60 min. | Drug: rtPA<br>* intravenous thrombolysis with rtPa<br>* Other names: alteplase;|
| urokinase<br>1,000,000-1,500,000 units of urokinase intravenous infused over 30 minutes within 4.5 h of stroke onset . | Drug: urokinase<br>* intravenous thrombolysis with urokinase<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excellent outcome at 3 months | The proportion of patients with excellent outcome (modified Rankin Score 0 to 1) at 3 months after stroke onset | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional independence at 3 months after stroke onset | the proportion of patients with functional independence (modified Rankin Scale, mRS, score 0-2) at 3 months after stroke onset | 90 days | 
| Symptomatic intracerebral haemorrhage | Symptomatic intracranial haemorrhages defined as NIHSS score increase ≥4 caused by intracranial hemorrhage | 22-36 hours | 
| Recurrent stroke | New stroke or TIA within 3 months | 90 days | 
| All-cause mortality | Death from all-cause death, stroke events or cardiovascular events | 1 day, 14 days, 90 days | 
| changes in NIHSS score | changes in NIHSS score at 1 day and 14 days, compared with baseline | 1 day, 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rtPA, urokinase