Intravenous Thrombolysis Registry for Chinese Ischemic Stroke Within 4.5 h Onset

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: rtPA; Drug: urokinase

• Registration Number: NCT02854592
• Lead Sponsor: General Hospital of Shenyang Military Region

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.

Study Timeline

• Study First Submitted: 2016-07-29
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-03
• Study Start: 2017-04-01
• Primary Completion: 2019-10-30
• Study Completion: 2019-10-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-15
• Last Update Posted: 2019-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rtPA	rtPA	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.
urokinase	urokinase	1,000,000-1,500,000 units of urokinase intravenous infused over 30 minutes within 4.5 h of stroke onset .

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

General Hospital of ShenYang Military Region; 🇨🇳 ShenYang, China