Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events(TRACE)
NCT ID: NCT04676659
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
240 participants
INTERVENTIONAL
2018-05-12
2020-07-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1 (rhTNK-tPA 0.10 mg/kg)
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.
TNK-tPA
Experimental arms for low, middle, and high dosing; and active control arm for the standard protocol
Group 2 (rhTNK-tPA 0.25 mg/kg)
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.
TNK-tPA
Experimental arms for low, middle, and high dosing; and active control arm for the standard protocol
Group 3 (rhTNK-tPA 0.32 mg/kg)
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.
TNK-tPA
Experimental arms for low, middle, and high dosing; and active control arm for the standard protocol
Group 4 (rt-PA 0.9 mg/kg)
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.
TNK-tPA
Experimental arms for low, middle, and high dosing; and active control arm for the standard protocol
Interventions
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TNK-tPA
Experimental arms for low, middle, and high dosing; and active control arm for the standard protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Time from onset to treatment \< 3 hours; the time symptoms start is defined as "the last moment they appear normal".
3. 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.
4. mRS \> 2 at the first onset or prior onset.
5. Baseline NIHSS score is \> 4 and \< 26.
6. Signed informed consent.
Exclusion Criteria
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 ≧ 180 mm Hg, or diastolic blood pressure ≧ 100 mm Hg; Increased blood pressure; 1.8 Active internal bleeding ; 1.9 Acute bleeding tendency, including platelet count below 100×109/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 )
2. 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.
3. Have been enrolled in rhTNK-tPA in pre-study or participated in other clinical trials within 3 months prior to screening.
4. Lactating women, or childbearing women who do not use effective contraception.
5. Known allergy to rhTNK-tPA and/or rt-PA or relevant excipients.
6. The researchers judged that not suitable to participate in this study or participate in this study may lead to greater risk for patients ;
7. Can not comply with the test program or follow-up requirements .
18 Years
ALL
No
Sponsors
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CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
INDUSTRY
The First Hospital Of Qiqihar
UNKNOWN
Hebei Medical University Third Hospital
OTHER
Yantai Yuhuangding Hospital
OTHER
Fudan University
OTHER
First Affiliated Hospital of Jinan University
OTHER
The First Hospital of Jilin University
OTHER
Huashan Hospital
OTHER
West China Hospital
OTHER
Inner Mongolia Baogang Hospital
OTHER
Linyi People's Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Baotou Central Hospital
OTHER
Beijing Tiantan Hospital
OTHER
Responsible Party
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Yongjun Wang
Vice President of Beijing Tiantan Hospital, Capital Medical University, Director of Neurology Center
Principal Investigators
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Meng Wang, MD,ph.D
Role: STUDY_DIRECTOR
IRB of Beijing Tiantan Hospital,Capital Medical University
Locations
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Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The Ninth People's Hospital of Chongqing
Chongqing, Chongqing Municipality, China
First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
ShenZhen Hospital ,Beijing University
Shenzhen, Guangdong, China
Affiliated Hosptial to GuiZhou Medical University
Guiyang, Guizhou, China
HaiNan Provincial People's Hospital
Haikou, Hainan, China
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China
Tangshan Workers' Hospital
Tangshan, Hebei, China
The First Hospital Of Qiqihar
Qiqihar, Heilongjiang, China
Luoyang First People's Hosptical
Luoyang, Henan, China
1st Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan, China
ChangSha 1st Municipal Hospital
Changsha, Hunan, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
Inner Mongolia BaoGang Hospital
Baotou, Inner Mongolia, China
Huai'an Second People's Hospital
Huai'an, Jiangsu, China
First Hospital of Jilin University
Changchun, Jilin, China
Meihekou Central Hospital
Tonghua, Jilin, China
First People 's Hospital Of Shenyang
Shenyang, Liaoning, China
General Hospital of Northern War Zone , PLA
Shenyang, Liaoning, China
Linyi People's Hospital
Linyi, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
HuaShan Hospital Affiliated to FuDan University
Shanghai, Shanghai Municipality, China
ZhongShan Hospital ,FuDan University
Shanghai, Shanghai Municipality, China
SiChuan University HuaXi Hospital
Chengdu, Sichuan, China
Countries
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References
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Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656.
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Lees GJ. Pharmacology of AMPA/kainate receptor ligands and their therapeutic potential in neurological and psychiatric disorders. Drugs. 2000 Jan;59(1):33-78. doi: 10.2165/00003495-200059010-00004.
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Huang X, Cheripelli BK, Lloyd SM, Kalladka D, Moreton FC, Siddiqui A, Ford I, Muir KW. Alteplase versus tenecteplase for thrombolysis after ischaemic stroke (ATTEST): a phase 2, randomised, open-label, blinded endpoint study. Lancet Neurol. 2015 Apr;14(4):368-76. doi: 10.1016/S1474-4422(15)70017-7. Epub 2015 Feb 26.
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Carlos A Monlina,Marc Ribo,Marta Rubiera,et al.TNK Induces Faster MCA Recanalization and Leads to Better Short- and Long-term Clinical Outcome Than Native tPA.The TNK-tPA Reperfusion Stroke Study.Stroke2008,39:527 Abstract141.
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Other Identifiers
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MK02-2016-01
Identifier Type: -
Identifier Source: org_study_id