Intravenous Thrombolysis Registry for Chinese Ischemic Stroke Within 4.5 h Onset (INTRECIS)

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ClinicalTrials.gov Identifier: NCT02854592

Recruitment Status : Completed

First Posted : August 3, 2016

Last Update Posted : December 17, 2019

Sponsor:

Information provided by (Responsible Party):

Hui-Sheng Chen, General Hospital of Shenyang Military Region

Study Description

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.

Condition or disease	Intervention/treatment
Ischemic Stroke	Drug: rtPA Drug: urokinase

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 Design

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Study Type :	Observational
Actual Enrollment :	4000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Intravenous Thrombolysis Registry for Chinese Ischemic Stroke Within 4.5 h Onset
Actual Study Start Date :	April 1, 2017
Actual Primary Completion Date :	October 30, 2019
Actual Study Completion Date :	October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Drug Information available for: Urokinase Alteplase

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	Drug: rtPA intravenous thrombolysis with rtPa Other Name: alteplase
urokinase 1,000,000-1,500,000 units of urokinase intravenous infused over 30 minutes within 4.5 h of stroke onset .	Drug: urokinase intravenous thrombolysis with urokinase

Outcome Measures

Primary Outcome Measures :

Excellent outcome at 3 months [ Time Frame: 90 days ]
The proportion of patients with excellent outcome (modified Rankin Score 0 to 1) at 3 months after stroke onset

Secondary Outcome Measures :

Functional independence at 3 months after stroke onset [ Time Frame: 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 [ Time Frame: 22-36 hours ]
Symptomatic intracranial haemorrhages defined as NIHSS score increase ≥4 caused by intracranial hemorrhage
Recurrent stroke [ Time Frame: 90 days ]
New stroke or TIA within 3 months
All-cause mortality [ Time Frame: 1 day, 14 days, 90 days ]
Death from all-cause death, stroke events or cardiovascular events
changes in NIHSS score [ Time Frame: 1 day, 14 days ]
changes in NIHSS score at 1 day and 14 days, compared with baseline

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with acute ischemic stroke within 4.5 hours of symptom onset

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854592

Locations

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China
General Hospital of ShenYang Military Region
ShenYang, China

Sponsors and Collaborators

General Hospital of Shenyang Military Region

Investigators

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Study Director:	Hui-Sheng Chen	General Hospital of Shenyang Military Region

More Information

Publications:

Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31.

Wang Y, Wu D, Zhao X, Ma R, Guo X, Wang C, Liu L, Zhao W, Wang Y. Hospital resources for urokinase/recombinant tissue-type plasminogen activator therapy for acute stroke in Beijing. Surg Neurol. 2009 Aug;72 Suppl 1:S2-7. doi: 10.1016/j.surneu.2007.12.028. Epub 2008 Apr 18.

European Stroke Organisation (ESO) Executive Committee; ESO Writing Committee. Guidelines for management of ischaemic stroke and transient ischaemic attack 2008. Cerebrovasc Dis. 2008;25(5):457-507. doi: 10.1159/000131083. Epub 2008 May 6.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cui Y, Meng WH, Chen HS. Early neurological deterioration after intravenous thrombolysis of anterior vs posterior circulation stroke: a secondary analysis of INTRECIS. Sci Rep. 2022 Feb 24;12(1):3163. doi: 10.1038/s41598-022-07095-6.

Wang X, Li X, Xu Y, Li R, Yang Q, Zhao Y, Wang F, Sheng B, Wang R, Chen S, Wang L, Shen L, Hou X, Cui Y, Wang D, Peng B, Anderson CS, Chen H; INTRECIS Investigators. Effectiveness of intravenous r-tPA versus UK for acute ischaemic stroke: a nationwide prospective Chinese registry study. Stroke Vasc Neurol. 2021 Dec;6(4):603-609. doi: 10.1136/svn-2020-000640. Epub 2021 Apr 26.

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Responsible Party:	Hui-Sheng Chen, Director of neurology department, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier:	NCT02854592
Other Study ID Numbers:	k2016-11
First Posted:	August 3, 2016 Key Record Dates
Last Update Posted:	December 17, 2019
Last Verified:	December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Hui-Sheng Chen, General Hospital of Shenyang Military Region:


rtPA urokinase

Additional relevant MeSH terms:

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Stroke Ischemic Stroke Cerebral Infarction Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases	Pathologic Processes Brain Infarction Brain Ischemia Infarction Necrosis Tissue Plasminogen Activator Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action

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