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

Sponsor

General Hospital of Shenyang Military Region (Other)

Overall Status

Completed

CT.gov ID

NCT02854592

Collaborator

(none)

4,000

Enrollment

Location

30.9

Actual Duration (Months)

129.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

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 :

Apr 1, 2017

Actual Primary Completion Date :

Oct 30, 2019

Actual Study Completion Date :

Oct 30, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Excellent outcome at 3 months [90 days]
The proportion of patients with excellent outcome (modified Rankin Score 0 to 1) at 3 months after stroke onset

Secondary Outcome Measures

Functional independence at 3 months after stroke onset [90 days]
the proportion of patients with functional independence (modified Rankin Scale, mRS, score 0-2) at 3 months after stroke onset
Symptomatic intracerebral haemorrhage [22-36 hours]
Symptomatic intracranial haemorrhages defined as NIHSS score increase ≥4 caused by intracranial hemorrhage
Recurrent stroke [90 days]
New stroke or TIA within 3 months
All-cause mortality [1 day, 14 days, 90 days]
Death from all-cause death, stroke events or cardiovascular events
changes in NIHSS score [1 day, 14 days]
changes in NIHSS score at 1 day and 14 days, compared with baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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