Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events(TRACE)
- Registration Number
- NCT04676659
- Lead Sponsor
- Beijing Tiantan Hospital
- Brief Summary
To explore the safe and efficacious dose of rhTNK-tPA injection administered within 3 hours after onset of hyperacute ischemic stroke; to provide dose evidence for phase III clinical trial.
- Detailed Description
To evaluate the safety and efficacy of rhTNK-tPA at different doses of 0.10 mg/kg, 0.25 mg/kg and 0.32 mg/kg compared with standard rt-PA intravenous thrombolytic therapy within 3 hours after onset of ischemic stroke. The primary objective of this study is to evaluate the differences of NIHSS scores among the four treatment groups at 14 days after intravenous thrombolysis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- Age over 18 years.
- Time from onset to treatment < 3 hours; the time symptoms start is defined as "the last moment they appear normal".
- Diagnosis of ischemic stroke according to "2014 China Guideline for Diagnosis and Treatment of Acute Ischemic Stroke" with assessable neurological impairment e.g., language, motor function, cognitive impairment, gaze impairment, visual field deficit and/or visual neglect. Ischemic stroke is defined as sudden acute focal neurological impairment with suspected cerebral ischemia, hemorrhage ruled out by CT scan.
- mRS > 2 at the first onset or prior onset.
- Baseline NIHSS score is > 4 and < 26.
- Signed informed consent.
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Absolute contraindications:
1.1 History of severe head trauma or stroke within 3 months; 1.2 Suspected subarachnoid hemorrhage; 1.3 Arterial puncture at a non-compressible site within the previous 1week; 1.4 History of intracranial hemorrhage; 1.5 Intracranial tumor, vascular malformation, or arterial aneurysm; 1.6 Recent intracranial or intraspinal surgery; 1.7 Systolic blood pressure β§ 180 mm Hg, or diastolic blood pressure β§ 100 mm Hg; Increased blood pressure; 1.8 Active internal bleeding ; 1.9 Acute bleeding tendency, including platelet count below 100Γ109/L or otherwise; 1.10 Heparin treatment was performed within 48 h ( APTT exceeded the upper limit of normal range ) ; 1.11 Warfarin has been taken orally , and the international standardized ratio is INR > 1.7 or PT > 15 s ; 1.12 Anticoagulant drugs such as thrombin inhibitor or Xa factor inhibitor , argatroban ( including new anticoagulants with unclear mechanism ) are currently being used , and various sensitive laboratory tests are abnormal ( such as live ) APTT , INR , Platelet count , Serpentine ECT of pulse enzyme setting time ; thrombin time TT or appropriate determination of Xa factor activity ) ; 1.13 Blood glucose < 2.7 mmol/L; 1.14 CT showed multilobular infarction ( low density > 1 / 3 cerebral hemisphere )
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Relative contraindications : The risks and benefits of thrombolysis should be carefully considered and weighed in the following cases ( that is , although there is one or more relative contraindications , it is not absolutely impossible to thrombolysis ).
2.1 Mild stroke or stroke with rapid improvement of symptoms; 2.2 Women in pregnancy ; 2.3 Symptoms of neurological impairment after seizures ; 2.4 There have been major surgical operations or serious injuries in the last 2 weeks; 2.5 There were gastrointestinal or urinary system bleeding in recent 3 weeks ; 2.6 History of myocardial infarction within 3 months.
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Have been enrolled in rhTNK-tPA in pre-study or participated in other clinical trials within 3 months prior to screening.
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Lactating women, or childbearing women who do not use effective contraception.
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Known allergy to rhTNK-tPA and/or rt-PA or relevant excipients.
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The researchers judged that not suitable to participate in this study or participate in this study may lead to greater risk for patients ;
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Can not comply with the test program or follow-up requirements .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 (rhTNK-tPA 0.10 mg/kg) TNK-tPA Dissolve one vial of rhTNK-tPA in 3 ml sterile water for injection to prepare a solution of 5.33 mg/ml. Calculate the required volume according to the body weight of the subject, then measure the required volume. Administer as a single 0.10 mg/kg IV bolus over 5-10 seconds. Group 2 (rhTNK-tPA 0.25 mg/kg) TNK-tPA Dissolve one vial of rhTNK-tPA in 3 ml sterile water for injection to prepare a solution of 5.33 mg/ml. Calculate the required volume according to the body weight of the subject, then measure the required volume. Administer as a single 0.25 mg/kg IV bolus over 5-10 seconds. Group 3 (rhTNK-tPA 0.32 mg/kg) TNK-tPA Dissolve one vial of rhTNK-tPA in 3 ml sterile water for injection to prepare a solution of 5.33 mg/ml. Calculate the required volume according to the body weight of the subject, then measure the required volume. Administer as a single 0.32 mg/kg IV bolus over 5-10 seconds. Group 4 (rt-PA 0.9 mg/kg) TNK-tPA 10% of rt-PA 0.9 mg/kg administered as an initial IV bolus followed by the remaining 90% as an IV infusion over the next 1 hour.
- Primary Outcome Measures
Name Time Method National Institutes of Health Stroke Scale (NIHSS) 14 days Proportion of subjects with NIHSS 1 or at least 4 on the NIHSS score decreased from the baseline at day14.
- Secondary Outcome Measures
Name Time Method National Institutes of Health Stroke Scale (NIHSS) 90 days Neurological impairment defined as change of NIHSS score at 90 days.
Barthel(BI) 90 days Global function of daily living defined as BI β₯ 95 at 90 days.
EQ-5D 90 days Quality of life measured by EQ-5D scale.
Modified Rankin Scale (mRS) 90 days 1. Proportion of subjects of excellent outcome defined as mRS (0-1) at 90 days.
2. Ordinal distribution of mRS and change of proportion of subjects with mRS (0-2) at 90 days.
Trial Locations
- Locations (24)
ZhongShan Hospital ,FuDan University
π¨π³Shanghai, Shanghai, China
1st Hospital Affiliated to Zhengzhou University
π¨π³Zhengzhou, Henan, China
SiChuan University HuaXi Hospital
π¨π³Chengdu, Sichuan, China
Beijing Tiantan Hospital, Capital Medical University
π¨π³Beijing, Beijing, China
The Ninth People's Hospital of Chongqing
π¨π³Chongqing, Chongqing, China
HaiNan Provincial People's Hospital
π¨π³Haikou, Hainan, China
First Affiliated Hospital of Jinan University
π¨π³Guangzhou, Guangdong, China
Affiliated Hosptial to GuiZhou Medical University
π¨π³Guiyang, Guizhou, China
ShenZhen Hospital ,Beijing University
π¨π³Shenzhen, Guangdong, China
Tangshan Workers' Hospital
π¨π³Tangshan, Hebei, China
Hebei Medical University Third Hospital
π¨π³Shijiazhuang, Hebei, China
The First Hospital Of Qiqihar
π¨π³Qiqihar, Heilongjiang, China
Luoyang First People's Hosptical
π¨π³Luoyang, Henan, China
ChangSha 1st Municipal Hospital
π¨π³Changsha, Hunan, China
Inner Mongolia BaoGang Hospital
π¨π³Baotou, Inner Mongolia, China
Huai'an Second People's Hospital
π¨π³Huai'an, Jiangsu, China
Baotou Central Hospital
π¨π³Baotou, Inner Mongolia, China
First Hospital of Jilin University
π¨π³Chang chun, Jilin, China
Meihekou Central Hospital
π¨π³Tonghua, Jilin, China
First People 's Hospital Of Shenyang
π¨π³Shenyang, Liaoning, China
General Hospital of Northern War Zone , PLA
π¨π³Shenyang, Liaoning, China
Linyi People's Hospital
π¨π³Linyi, Shandong, China
HuaShan Hospital Affiliated to FuDan University
π¨π³Shanghai, Shanghai, China
Yantai Yuhuangding Hospital
π¨π³Yantai, Shandong, China