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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

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.

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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


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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. Symptomatic intracerebral haemorrhage [ Time Frame: 22-36 hours ]
    Symptomatic intracranial haemorrhages defined as NIHSS score increase ≥4 caused by intracranial hemorrhage

  3. Recurrent stroke [ Time Frame: 90 days ]
    New stroke or TIA within 3 months

  4. All-cause mortality [ Time Frame: 1 day, 14 days, 90 days ]
    Death from all-cause death, stroke events or cardiovascular events

  5. changes in NIHSS score [ Time Frame: 1 day, 14 days ]
    changes in NIHSS score at 1 day and 14 days, compared with baseline



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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

Information from the National Library of Medicine

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
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action