Intravenous Thrombolysis Registry for Chinese Ischemic Stroke Within 4.5 h Onset

NCT ID: NCT02854592

Last Updated: 2019-12-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2019-10-30

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.

Conditions

Ischemic Stroke

Keywords

rtPA; urokinase

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

rtPA

Intervention Type: DRUG

intravenous thrombolysis with rtPa

urokinase

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

urokinase

Intervention Type: DRUG

intravenous thrombolysis with urokinase

Interventions

rtPA

intravenous thrombolysis with rtPa

Intervention Type: DRUG

urokinase

intravenous thrombolysis with urokinase

Intervention Type: DRUG

Other Intervention Names

alteplase

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Director of neurology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui-Sheng Chen

Role: STUDY_DIRECTOR

General Hospital of Shenyang Military Region

Locations

General Hospital of ShenYang Military Region

Shenyang, , China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 23370205 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18423545 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18477843 (View on PubMed)

Cui Y, Wang XH, Zhao Y, Chen SY, Sheng BY, Wang LH, Chen HS. Association of serum biomarkers with early neurologic improvement after intravenous thrombolysis in ischemic stroke. PLoS One. 2022 Oct 31;17(10):e0277020. doi: 10.1371/journal.pone.0277020. eCollection 2022.

Reference Type: DERIVED

PMID: 36315566 (View on PubMed)

Cui Y, Yao ZG, Chen HS. Intravenous thrombolysis with 0.65 mg/kg r-tPA may be optimal for Chinese mild-to-moderate stroke. Front Neurol. 2022 Sep 20;13:989907. doi: 10.3389/fneur.2022.989907. eCollection 2022.

Reference Type: DERIVED

PMID: 36203975 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35720096 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35210531 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33903179 (View on PubMed)

Other Identifiers

k2016-11

Identifier Type: -

Identifier Source: org_study_id