Status:
COMPLETED
Thrombolysis of Urokinase for Minor Stroke
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University
Collaborating Sponsors:
Beijing Tiantan Hospital
Shanghai 10th People's Hospital
Conditions:
Minor Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 evalua...
Detailed Description
China is currently faced with the heaviest stroke burden due to the tremendous population and susceptibility to cerebrovascular disease. As has been assessed, deaths caused by cerebrovascular disease ...
Eligibility Criteria
Inclusion
- Adult patients: 18-80 years old
- The time from last seen well to treatment \< 6 hours
- Minor stroke defined as a baseline NIHSS ≤5 at the time of randomization..
- First onset or pre-stroke mRS≤1
- Informed consent signed
Exclusion
- Hyperdensity on CT suggesting intracranial hemorrhage
- Large acute stroke \>1/3 middle cerebral artery (MCA) territory visible on CT or MRI
- Other contraindications of intravenous thrombolysis, including but not limited to:
- Intracranial tumor, arteriovenous malformation
- Coma or confirmed as severe stroke by clinical assessment (e.g. NIHSS ≥25) or proper imaging methods
- With seizure
- Stroke attack within past three months
- Heparin administration within 48h before onset, with APTT longer than upper limit
- Stroke history with diabetes
- Platelet count ≤100×10\^9/L
- 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.
- Blood glucose \<50mg/dl（2.7mmol/l）or \>400mg/dl（22.2mmol/l）
- Obvious hemorrhage within past 6 months
- Oral anti-coagulation drug administration (e.g. warfarin) with INR\>1.5
- Intracranial hemorrhage or suspected intracranial hemorrhage (including subarachnoid hemorrhage)
- Pregnancy or lactation.
- History of severe CNS damage (e.g. tumor, arterial aneurysm or CNS surgery)
- Hemorrhagic retinopathy, e.g. diabetes (hemorrhages suggested by optic impairment) or other hemorrhagic ocular lesions.
- Bacterial endocarditis or pericarditis.
- Prolonged or traumatic CPR (\>2min), puncture in nonstress vessels within past 10 days, such as subclavian vein puncture.
- Acute pancreatitis.
- Confirmed ulcerative gastric or intestinal problems within 3 months.
- Arterial aneurysm or arteriovenous malformation.
- Any tumor that increase risk of hemorrhage.
- Severe hepatic diseases, like hepatic failure, liver cirrhosis, portal hypertension, esophageal varices or active hepatitis.
- Major surgery, severe trauma or craniocerebral trauma within past 10 days.
- Allergy to any components of urokinase.
- Severe, fatal diseases with less than 3 month expected survival.
- Intended to receive standard rt-PA thrombolysis or intravascular therapy.
- Already participating in other studies that conflict to this study.
- Unable to accomplish the follow-up.
Key Trial Info
Start Date :
October 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2023
Estimated Enrollment :
1005 Patients enrolled
Trial Details
Trial ID
NCT04420351
Start Date
October 4 2020
End Date
February 18 2023
Last Update
November 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 0371