Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China
Intravenous ThrombolysisRegistry for Acute Ischemic Stroke in China
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Contacts and Locations
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China
- General Hospital of Shenyang Military Region
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 1) age> 18 years old;
- 2) meet the diagnostic criteria of China 2014 guidelines for the diagnosis and treatment of acute ischemic stroke;
- 3) no history of first sepsis or previous cerebral infarction sequelae (mRS ≤ 1);
- 4) within 3 hours of onset;
- 5) Have measurable neurological deficits;
- 6) Patients or legal guardians can understand and sign informed consent.
Exclusion Criteria:
- Absolute exclusion criteria:
- 1) history of head trauma or stroke within the last 3 months;
- 2) suspected subarachnoid hemorrhage;
- 3) history of previous intracranial hemorrhage;
- 4) intracranial tumor, arteriovenous malformation or aneurysm ;
- 5) recent intracranial or intraspinal surgery;
- 6) arterial puncture at an incurable site within the last 7 days;
- 7) elevated blood pressure: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg;
- 8) Internal bleeding;
- 9) acute bleeding tendency, including platelet count less than 100 × 109 / L or other conditions;
- 10) heparin treatment within 48 h (APTT is outside the upper limit of normal range);
- 11) oral anticoagulant, INR> 1.7 Or PT> 15S;
- 12) are currently using thrombin inhibitors or factor Xa inhibitors, various sensitive laboratory abnormalities (such as APTT, INR, platelet count, ECT; TT or appropriate factor Xa activity assays) ;
- 13) Blood glucose <50 mg / dl (2.7 mmol / L);
- 14) CT suggestive of multiple cerebral infarction (low density range> 1/3 of the cerebral hemispheres) ;
- 15) Other conditions considered unsuitable for inclusion in this clinical study;
- 16) 3 months or are participating in other clinical trials;
- 17) combined with severe systemic disease is expected to survive less than three months.
- Relative exclusion criteria:
- 1) severe stroke (NIHSS> 25 points);
- 2) pregnancy;
- 3) neurological deficits after epileptic seizures;
- 4) major surgery or severe trauma within the last 14 days;
- 5) Urethral hemorrhage;
- 6) Myocardial infarction within the last 3 months;
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Alteplase group
According to 0.6-0.9mg
/ kg alteplase (maximum can not exceed 90mg), of which 10% intravenous injection, the remaining 60 minutes intravenous infusion
|
According to 0.6-0.9mg
/ kg alteplase (maximum can not exceed 90mg), of which 10% intravenous injection, the remaining 60 minutes intravenous infusion.
|
|
Urokinase group
1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously End
|
1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mRS of 90 days after thrombolysis
Time Frame: Month 3
|
Proportion of patients with mRS = 0-1 points 90 days after thrombolysis
|
Month 3
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of Adverse events
Time Frame: Year 1
|
Symptomatic intracranial hemorrhage conversion rate; Liver and kidney dysfunction; Bleeding gums; Skin mucous membrane bleeding
|
Year 1
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Economic evaluation
Time Frame: Day 14
|
The cost-effectiveness of different thrombolytic drugs
|
Day 14
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Huisheng Chen, doctor, Neurology Chief
Study record dates
Study Major Dates
Study Start (Anticipated)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Brain Ischemia
- Infarction
- Brain Infarction
- Stroke
- Ischemic Stroke
- Ischemia
- Cerebral Infarction
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Tissue Plasminogen Activator
Other Study ID Numbers
Other Study ID Numbers
- K201707
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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