Intravenous Thrombolysis Registry for Chinese Ischemic Stroke Within 4.5 h Onset

Ischemic Stroke Clinical Trial

— INTRECIS  

Official title:

Intravenous Thrombolysis Registry for Chinese Ischemic Stroke Within 4.5 h Onset

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854592
• Other study ID #: k2016-11
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: October 30, 2019

Study information

• Verified date: December 2019
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• rtPA
intravenous thrombolysis with rtPa
• urokinase
intravenous thrombolysis with urokinase

Locations

Country	Name	City	State
China	General Hospital of ShenYang Military Region	ShenYang

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Symptomatic intracerebral haemorrhage	Symptomatic intracranial haemorrhages defined as NIHSS score increase =4 caused by intracranial hemorrhage	22-36 hours
Secondary	Recurrent stroke	New stroke or TIA within 3 months	90 days
Secondary	All-cause mortality	Death from all-cause death, stroke events or cardiovascular events	1 day, 14 days, 90 days
Secondary	changes in NIHSS score	changes in NIHSS score at 1 day and 14 days, compared with baseline	1 day, 14 days