Ischemic Stroke
Conditions
Keywords
rtPA, urokinase
Brief summary
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
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.
Interventions
Sponsors
General Hospital of Shenyang Military Region
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excellent outcome at 3 months | 90 days | The proportion of patients with excellent outcome (modified Rankin Score 0 to 1) at 3 months after stroke onset |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional independence at 3 months after stroke onset | 90 days | the proportion of patients with functional independence (modified Rankin Scale, mRS, score 0-2) at 3 months after stroke onset |
| Symptomatic intracerebral haemorrhage | 22-36 hours | Symptomatic intracranial haemorrhages defined as NIHSS score increase ≥4 caused by intracranial hemorrhage |
| Recurrent stroke | 90 days | New stroke or TIA within 3 months |
| All-cause mortality | 1 day, 14 days, 90 days | Death from all-cause death, stroke events or cardiovascular events |
| changes in NIHSS score | 1 day, 14 days | changes in NIHSS score at 1 day and 14 days, compared with baseline |
Countries
China
Outcome results
None listed