Intravenous Thrombolysis Registry for Chinese Ischemic Stroke Within 4.5 h Onset

NCT02854592 | Completed DMC

• 1 other identifier: k2016-11
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

rtPA; urokinase

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Functional independence at 3 months after stroke onset

  90 days

• Symptomatic intracerebral haemorrhage

  22-36 hours

• Recurrent stroke

  90 days

• All-cause mortality

  1 day, 14 days, 90 days

• changes in NIHSS score

  1 day, 14 days

Study Arms (2)

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

urokinase

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

Drug: urokinase

Interventions

rtPA DRUG

intravenous thrombolysis with rtPa

Also known as: alteplase

rtPA

urokinase DRUG

intravenous thrombolysis with urokinase

urokinase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute ischemic stroke within 4.5 hours of symptom onset

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General Hospital of ShenYang Military Region

Shenyang, China

Location

Related Publications (8)

• 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.

  PMID: 23370205 BACKGROUND

• 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.

  PMID: 18423545 BACKGROUND

• 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.

  PMID: 18477843 BACKGROUND

• 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.

  PMID: 36315566 DERIVED

• 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.

  PMID: 36203975 DERIVED

• 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.

  PMID: 35720096 DERIVED

• 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.

  PMID: 35210531 DERIVED

• 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.

  PMID: 33903179 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tissue Plasminogen Activator; Urokinase-Type Plasminogen Activator

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Hui-Sheng Chen

  General Hospital of Shenyang Military Region

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of neurology department

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 3, 2016
• Study Start: April 1, 2017
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)