Clinical trial NCT02854592: Intravenous Thrombolysis Registry for Chinese Ischemic Stroke Within 4.5 h Onset
Official title: Intravenous Thrombolysis Registry for Chinese Ischemic Stroke Within 4.5 h Onset
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: rtPA
urokinase
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute ischemic stroke within 4.5 hours of symptom onset

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.

Eligibility criteria: 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

Primary outcomes:
measure: Excellent outcome at 3 months
timeFrame: 90 days
Secondary outcomes:
measure: Functional independence at 3 months after stroke onset
timeFrame: 90 days
measure: Symptomatic intracerebral haemorrhage
timeFrame: 22-36 hours
measure: Recurrent stroke
timeFrame: 90 days
measure: All-cause mortality
timeFrame: 1 day, 14 days, 90 days
measure: changes in NIHSS score
timeFrame: 1 day, 14 days
Other outcomes:
Locations:
city: ShenYang
country: China
facility: General Hospital of ShenYang Military Region
Study officials:
affiliation: General Hospital of Shenyang Military Region
name: Hui-Sheng Chen
role: STUDY_DIRECTOR
References:
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citation: Cui Y, Wang XH, Zhao Y, Chen SY, Sheng BY, Wang LH, Chen HS. Change of Serum Biomarkers to Post-Thrombolytic Symptomatic Intracranial Hemorrhage in Stroke. Front Neurol. 2022 Jun 2;13:889746. doi: 10.3389/fneur.2022.889746. eCollection 2022.
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