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

December 15, 2019 updated by: Hui-Sheng Chen, General Hospital of Shenyang Military Region
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • ShenYang, China
        • General Hospital of Shenyang Military Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with acute ischemic stroke within 4.5 hours of symptom onset

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Shenyang Military Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2017

Primary Completion (ACTUAL)

October 30, 2019

Study Completion (ACTUAL)

October 30, 2019

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (ESTIMATE)

August 3, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 15, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • k2016-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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