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A multicenter, randomized clinical trial of intravenous thrombolysis with a low dose versus a standard dose of alteplase in early acute ischemic stroke with leukoaraiosis.

A multicenter, randomized clinical trial of intravenous thrombolysis with a low dose versus a standard dose of alteplase in early acute ischemic stroke with leukoaraiosis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049167
Enrollment
Unknown
Registered
2021-07-24
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Interventions

Experimental group1:Standard dose alteplase
Experimental group2:low-dose alteplase

Sponsors

Xianyang Hospital of Yan 'an University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years; 2. The clinical symptoms are consistent with the diagnosis of ischemic stroke; 3. The time from onset to randomization is within 4.5 hours; 4. National Institutes of Health Stroke Scale (NIHSS) score 4-25; 5. CT scan indicates that the early signs of cerebral infarction are negative; 6. Cranial CT was used to evaluate leukoaraiosis, the modified Van Swieten Scale score was >=1 point, and it was decided to undergo intravenous alteplase thrombolysis; 7. Patients or their families signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. With evidence of active internal hemorrhage or trauma fracture, intracranial hemorrhage cannot be excluded, including suspected subarachnoid hemorrhage; 2. Very slight or rapid improvement of neurological dysfunction; 3. mRS score >= 2 points before the onset; 4. The time of onset cannot be determined, and the maximum possible time from onset to the start of thrombolytic therapy exceeds 4.5 hours; 5. Neurological deficits are considered to be caused by epileptic seizures; 6. History of intracranial hemorrhage, arteriovenous malformation or intracranial aneurysm; 7. A history of intracranial surgery, head trauma or symptomatic ischemic stroke within the last 3 months, a history of surgery within the last 14 days, and a history of lumbar puncture or arterial puncture that is not suitable for hemostasis in the last 7 days; 8. Pregnancy; 9. Significant bleeding risk, platelet count 1.5; 10. Blood sugar 185mmHg or diastolic blood pressure >110mmHg before thrombolytic therapy; 12. CT has shown early cerebral infarction with low density > 1/3 of the middle cerebral artery blood supply area; 13. Accept endovascular interventional therapy; 14. Patients with chronic hemodialysis and severe renal insufficiency (glomerular filtration rate 220umol/L (2.5mg/dl)); 15. Patients with malignant tumors and patients undergoing chemotherapy; 16. The life expectancy of any advanced disease is less than 6 months; 17. Not expected to complete follow-up.

Design outcomes

Primary

MeasureTime frame
Modified Rankin Scale score;Incidence of intracranial hemorrhage;mortality rate;

Countries

China

Contacts

Public ContactXu Jiaping

Xianyang Hospital of Yan 'an University

2322445024@qq.com+86 15991006516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026