Thrombolysis of Urokinase for Minor Stroke

• Status: Not yet recruiting
• Trial end date: 2021-12-18
• Target enrollment: 0
• Participant gender: All

Summary

This trial will enroll patients that have been diagnosed with minor stroke, which has occurred within the past 6 hours. TRUST is a prospective multicenter, randomized, blinded-endpoint study to evaluate the efficacy and safety of Urokinase Thrombolysis for patients with minor stroke.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University
• Collaborators: Beijing Tiantan Hospital; General Hospital of Shenyang Military Region; Shanghai 10th People's Hospital
• Treatments: Aspirin; Clopidogrel

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.