Clinical Research of Intravenous Thrombolysis for Ischemic Stroke in Northeast of China
NCT ID: NCT05028868
Last Updated: 2024-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2015-06-01
2026-01-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Large artery atherosclerosis(LAA)
No interventions assigned to this group
Cardiogenic stroke(CS)
No interventions assigned to this group
Penetrating artery disease(PAD)
No interventions assigned to this group
Other etiology(OE)
No interventions assigned to this group
undetermined etiology(UE)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Onset of symptoms \<4.5 h before treatment begins
3. Age ≥18 y
Exclusion Criteria
2. Symptoms suggest SAH
3. Arterial puncture at noncompressible site in previous 7 d
4. History of previous intracranial hemorrhage
5. Intracranial neoplasm, AVM, or aneurysm
6. Recent intracranial or intraspinal surgery
7. Elevated blood pressure (systolic \>185 mm Hg or diastolic \>110 mm Hg)
8. Active internal bleeding
9. Acute bleeding diathesis, including but not limited to
10. Platelet count \<100 000/mm3
11. Heparin received within 48 h resulting in abnormally elevated aPTT above the upper limit of normal
12. Current use of anticoagulant with INR \>1.7 or PT \>15 s
13. Current use of direct thrombin inhibitors or direct factor Xa inhibitors with elevated sensitive laboratory tests (eg, aPTT, INR, platelet count, ECT, TT, or appropriate factor Xa activity assays)
14. Blood glucose concentration \<50 mg/dL (2.7 mmol/L)
15. CT demonstrates multilobar infarction (hypodensity \>1/3 cerebral hemisphere)
17. Recent experience suggests that under some circumstances, with careful consideration and weighting of risk to benefit, patients may receive fibrinolytic therapy despite ≥1 relative contraindications. Consider risk to benefit of intravenous rtPA administration carefully if any of these relative contraindications is present
18. Only minor or rapidly improving stroke symptoms (clearing spontaneously)
19. Pregnancy
20. Seizure at onset with postictal residual neurological impairments
21. Major surgery or serious trauma within previous 14 d
22. Recent gastrointestinal or urinary tract hemorrhage (within previous 21 d)
23. Recent acute myocardial infarction (within previous 3 mo)
18 Years
ALL
No
Sponsors
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Yi Yang
OTHER
Responsible Party
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Yi Yang
Associate dean, Director of Cerebrovascular Disease Center
Principal Investigators
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Yi Yang, MD，PhD
Role: STUDY_CHAIR
The First Hospital of Jilin University
Locations
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First Hospital of Jilin University
Changchun, Jilin, China
Countries
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Central Contacts
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Facility Contacts
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References
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Zhang HM, Shen ZD, Qu Y, Zhang P, Abuduxukuer R, Wang LJ, Li Y, Chen YM, Liu AR, Liu XD, Zhao LL, Yang CY, Yao J, Wang AY, Jiang YF, Wang JC, Dong CP, Liu FF, Li L, Qi YB, Wang CF, Li H, Zhang LY, Ma WJ, Guo ZN, Yang Y. External validation of N2H3 nomogram to predict outcomes in patients with acute ischemic stroke treated by intravenous thrombolysis. Brain Circ. 2025 Mar 4;11(3):212-218. doi: 10.4103/bc.bc_81_24. eCollection 2025 Jul-Sep.
Other Identifiers
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CRISTINA
Identifier Type: -
Identifier Source: org_study_id
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