Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebr... | NCT04797013

Status Module

Name	Class
CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rhTNK-tPA (0.25mg/kg)	Active Comparator	rhTNK-tPA (0.25mg/kg) is given as a single, intravenous bolus (within 5-10 seconds) immediately upon randomization. Maximum dose 25mg.	Drug: rhTNK-tPA
rt-PA (0.9mg/kg)	Active Comparator	10% dose of rt-PA (0.9 mg/kg) is given as bolus and the remainder in 1 hour. Maximum dose 90mg.	Drug: rt-PA

Name	Type	Description	Arm Group Labels	Other Names
rt-PA	Drug	Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.	rt-PA (0.9mg/kg)

Outcomes Module

Measure	Description	Time Frame
Excellent functional outcome	Proportion of subjects with mRS(0-1) at 90 days.	90 days

Secondary Outcomes

Measure	Description	Time Frame
Good functional outcome	Proportion of subjects with mRS(0-2) at 90 days.	90 days
National Institutes of Health Stroke Scale (NIHSS)	Proportion of subjects with NIHSS score ≥ 4 improved compared with baseline at 24 or with NIHSS 0-1 at 24 hours and 7 days.

Other Outcomes

Measure	Description	Time Frame
Symptomatic intracranial hemorrhage(sICH)	Proportion of subjects with symptomatic intracranial hemorrhage (sICH) at 36 hours.( defined by ECASSIII)	36 hours
Asymptomatic intracranial hemorrhage	The incidence of asymptomatic intracranial hemorrhage at 90 days.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥18 years old, no gender limitation;
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";
The clinical diagnosis was ischemic stroke (the diagnosis followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018);
MRS before onset was 0-1 points
Baseline NIHSS 5-25(both included);
Informed consent from the patient or surrogate.

Exclusion Criteria:

Intended to proceed endovascular treatment;
NIHSS consciousness score >2;
Allergy to tenecteplase or alteplase;
Past history of intracranial hemorrhage ;
A history of severe head trauma or stroke within 3 months;
A history of intracranial or spinal surgery within 3 months;
A history of gastrointestinal or urinary bleeding within 3 weeks;
2 weeks of major surgery;
Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week;
Intracranial tumors (except neuroectodermal tumors, such as meningiomas), large intracranial aneurysms;
Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);
Active visceral bleeding;
Aortic arch dissection was found;
After active antihypertensive treatment, hypertension is still not under control: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg;
Propensity for acute bleeding, including platelet counts of less than 100×109/ L or otherwise;
Blood glucose <2.8 mmol/L or >22.22 mmol/L;
Oral warfarin anticoagulant with INR>1.7 or PT>15 s;
Heparin treatment was received within 24 h;
Thrombin inhibitors or factor Xa inhibitors were used within 48 h;
Head CT or MRI showed a large infarction (infarcted area > 1/3 of the middle cerebral artery);
Subjects who are unable or unwilling to cooperate due to hemiplegia (Todd's palsy) after epileptic seizure or other neurological/psychiatric disorders;
Pregnant women, lactating women, or subjects who do not agree to use effective contraception during the trial;
Participation in other clinical trials within 3 months prior to screening;
Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.

Name	Affiliation	Role
Wei Sun	IRB of Beijing Tiantan Hospital,Capital Medical University	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
The first affiliated hospital of ustc		Hefei	Anhui	230000	China
The people's hospltal of xuancheng city

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32078683	Background	Campbell BCV, Mitchell PJ, Churilov L, Yassi N, Kleinig TJ, Dowling RJ, Yan B, Bush SJ, Thijs V, Scroop R, Simpson M, Brooks M, Asadi H, Wu TY, Shah DG, Wijeratne T, Zhao H, Alemseged F, Ng F, Bailey P, Rice H, de Villiers L, Dewey HM, Choi PMC, Brown H, Redmond K, Leggett D, Fink JN, Collecutt W, Kraemer T, Krause M, Cordato D, Field D, Ma H, O'Brien B, Clissold B, Miteff F, Clissold A, Cloud GC, Bolitho LE, Bonavia L, Bhattacharya A, Wright A, Mamun A, O'Rourke F, Worthington J, Wong AA, Levi CR, Bladin CF, Sharma G, Desmond PM, Parsons MW, Donnan GA, Davis SM; EXTEND-IA TNK Part 2 investigators. Effect of Intravenous Tenecteplase Dose on Cerebral Reperfusion Before Thrombectomy in Patients With Large Vessel Occlusion Ischemic Stroke: The EXTEND-IA TNK Part 2 Randomized Clinical Trial. JAMA. 2020 Apr 7;323(13):1257-1265. doi: 10.1001/jama.2020.1511.
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ID	Term
D000083242	Ischemic Stroke
D020521	Stroke

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D010959	Tissue Plasminogen Activator
D007267	Injections

ID	Term
D012697	Serine Endopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes
D057057	Serine Proteases
D010960	Plasminogen Activators
D001779	Blood Coagulation Factors
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D001685	Biological Factors
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics