Clinical study of intravenous thrombolysis in acute ischemic stroke with an extended time window

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300078528

Enrollment

Unknown

Registered

2023-12-11

Start date

2023-12-11

Completion date

Unknown

Last updated

2023-12-19

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

Conditions

Ischemic stroke

Interventions

The treatment group:Intravenous thrombolysis + drug treatment according to guidelines

The control group:Drug treatment according to guidelines

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Those who meet the diagnosis of acute ischemic stroke 2. Patients over 18 years old have no gender limit 3. The course of acute onset is within 4.5 ~ 24h (If it is a wake-up stroke, it will be calculated from the middle time from falling asleep to waking up) 4. NIHSS 4-26 points; 5. Core infarct volume 10mL and hypoperfusion volume/core infarct volume > 1.2; 6. mRS < 2 points before this stroke; 7. According to the guidelines, there is no indication of arterial embolectomy or family members refuse arterial embolectomy; 8. Volunteer, sign written informed consent, the process of obtaining informed consent shall comply with the GCP

Exclusion criteria

Exclusion criteria: 1. There is obvious head trauma or stroke in the last 3 months; 2. Symptoms suggest subarachnoid space; 3. There is arterial puncture in the last 7 days; 4. Have a history of intracranial hemorrhage; 5. Intracranial tumors, arteriovenous malformations, and aneurysms;; 6. Recent intracranial or spinal cord surgery; 7. High blood pressure (systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg); 8. Active internal hemorrhage; 9. Acute qualities include but are not limited to: platelet count 1.7 or PT > 15 seconds; Elevated laboratory indices in which direct thrombin inhibitors or direct factor XA inhibitors are being used (e.g. aPTT, INR, platelet count and snake vein enzyme coagulation time (ECT); thrombin time (TT); or appropriate factor XA assay); 10. Blood glucose concentration 1/3 cerebral hemisphere)

Design outcomes

Primary

Measure	Time frame
mRS score after 90 days;	—

Secondary

Measure	Time frame
NIHSS scores after 24 hours and 7 days;	—

Countries

China

Contacts

Public ContactMinghua Wu

Jiangsu Province Hospital of Chinese Medicine

mhuawu@163.com+86 139 5178 6719

Outcome results

None listed

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