Status:
UNKNOWN
Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-II）
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
Jiangsu FENG HUA Biotech Pharmaceutical Co., Ltd
The Place Pharmaceutical(Jiangsu) Co., Ltd
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The trial is prospective, block randomized, open-label, blinded endpoint (PROBE) design. Patients with acute ischemic stroke, who are eligible for standard intravenous thrombolysis within 4.5 hours of...
Detailed Description
The study will be a multi-center, prospective, randomized, open- label, blinded endpoint (PROBE), controlled phase 2 trial (3 arm with 1:1:1 randomization) in ischemic stroke patients. Imagine is perf...
Eligibility Criteria
Inclusion
- Age ≥18 years old;
- The clinical diagnosis was Acute ischemic stroke The time from onset to treatment was \< 4.5h; The time at which symptoms begin is defined as "the time at which they finally appear normal";
- mRS before onset was ≤1 points;
- Baseline NIHSS (at the time of randomization) should be \> 5 and ≤25 points;
- Informed consent from the patient or surrogate.
Exclusion
- Intracranial hemorrhage identified by CT or MRI (CMBs detected by SWI is not counted);
- Massive anterior cerebral infarction identified by CT or MRI (ASPECT \< 6 or lesions larger than one third of the territory of the middle cerebral artery or with a volume larger than 70mL)
- A history of severe CNS damage (such as aneurysm or arteriovenous malformation, craniocerebral trauma, intracranial or spinal cord surgery)
- Onset with seizures, and the paralysis was suspected to be related to Todd paralysis.
- Administration of heparin within 48 hours preceding the onset of stroke with a baseline APTT exceeding the upper limit of the normal range.
- Oral anticoagulant (such as warfarin) treatment with baseline INR\>1.7 or PT\>15 s;
- Administration of thrombin inhibitors or factor Xa inhibitors within 48 hours preceding the onset of stroke with abnormal coagulation parameters or platelet count;
- BP couldn't be controlled with aggressive treatment. Uncontrolled hypertension was defined as systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, measured for three times every 10 minutes.
- Platelet count of less than 100×109/ L;
- Blood glucose \<50 mg/dl (\<2.8 mmol/L) or \>400 mg/dl (22.22 mmol/L);
- History of intracranial hemorrhage or active hemorrhagic disease. (Such as gastrointestinal, urinary tract or retinal bleeding)
- Tumors with an increased risk of bleeding.
- Prolonged or traumatic cardiopulmonary resuscitation (\>2 min), delivery within the last 10 days or recent puncture of non-compression vessels such as subclavian vein or jugular vein
- Acute pancreatitis or severe liver disease, including liver failure, cirrhosis, portal hypertension, esophageal varicose veins, and active hepatitis;
- Aortic arch dissection;
- Major surgery or severe trauma in the past 2 weeks;
- Subjects had serious, fatal, or disabling disease with an expected survival of less than 3 months;
- Unable to complete neurological assessment and follow-up visits because of dementia or mental illness;
- Pregnant women, lactating women, or have positive pregnancy test;
- Allergy to tenecteplase or alteplase or their components;
- Participation in other clinical trials within 3 months prior to screening;
- Unsuitable to involve in this study or would result in increased risk, as judged by the investigators.
Key Trial Info
Start Date :
May 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2022
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT05281549
Start Date
May 2 2021
End Date
May 31 2022
Last Update
March 31 2022
Active Locations (28)
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1
Beijing Tiantan Hospital, Capital Medical University Beijing
Beijing, Beijing Municipality, China, 100000
2
Quanzhou First Hospital
Quanzhou, Fujian, China, 362000
3
Yue Bei People'S Hospital
Shaoguan, Guangdong, China, 512000
4
Hengshui people's Hospital (Harrison International Peace Hospital)
Hengshui, Hebei, China, 053000