Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT04420351
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients: 18-80 years old
2. The time from last seen well to treatment \< 6 hours
3. Minor stroke defined as a baseline NIHSS ≤5 at the time of randomization..
4. First onset or pre-stroke mRS≤1
5. Informed consent signed
Exclusion Criteria:
1.Hyperdensity on CT suggesting intracranial hemorrhage
2.Large acute stroke \>1/3 middle cerebral artery (MCA) territory visible on CT or MRI
3.Other contraindications of intravenous thrombolysis, including but not limited to:
1. Intracranial tumor, arteriovenous malformation
2. Coma or confirmed as severe stroke by clinical assessment (e.g. NIHSS ≥25) or proper imaging methods
3. With seizure
4. Stroke attack within past three months
5. Heparin administration within 48h before onset, with APTT longer than upper limit
6. Stroke history with diabetes
7. Platelet count ≤100×10\^9/L
8. Difficult to control hypertension, defined by systolic pressure ≥185mmHg or diastolic pressure ≥110 mmHg in 3 tests with at least ten minutes interval, under well guided medications.
9. Blood glucose \<50mg/dl（2.7mmol/l）or \>400mg/dl（22.2mmol/l）
10. Obvious hemorrhage within past 6 months
11. Oral anti-coagulation drug administration (e.g. warfarin) with INR\>1.5
12. Intracranial hemorrhage or suspected intracranial hemorrhage (including subarachnoid hemorrhage)
13. Pregnancy or lactation.
14. History of severe CNS damage (e.g. tumor, arterial aneurysm or CNS surgery)
15. Hemorrhagic retinopathy, e.g. diabetes (hemorrhages suggested by optic impairment) or other hemorrhagic ocular lesions.
16. Bacterial endocarditis or pericarditis.
17. Prolonged or traumatic CPR (\>2min), puncture in nonstress vessels within past 10 days, such as subclavian vein puncture.
18. Acute pancreatitis.
19. Confirmed ulcerative gastric or intestinal problems within 3 months.
20. Arterial aneurysm or arteriovenous malformation.
21. Any tumor that increase risk of hemorrhage.
22. Severe hepatic diseases, like hepatic failure, liver cirrhosis, portal hypertension, esophageal varices or active hepatitis.
23. Major surgery, severe trauma or craniocerebral trauma within past 10 days.
24. Allergy to any components of urokinase.
4.Severe, fatal diseases with less than 3 month expected survival.
5.Intended to receive standard rt-PA thrombolysis or intravascular therapy.
6.Already participating in other studies that conflict to this study.
7.Unable to accomplish the follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04420351
Study Brief:
Protocol Section:
NCT04420351