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Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ (TRACEⅡ)

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ClinicalTrials.gov Identifier: NCT04797013
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : July 28, 2021
Sponsor:
Collaborator:
Guangzhou Recomgen Biotech Co., Ltd.
Information provided by (Responsible Party):
Yongjun Wang, Beijing Tiantan Hospital

Brief Summary:
A Phase Ⅲ, Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Injection Versus Alteplase for Acute Ischemic Stroke Within 4.5 Hours

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: rt-PA Drug: rhTNK-tPA Phase 3

Detailed Description:
To test the hypothesis that rhTNK-tPA is non-inferior to alteplase in thrombolysis treatment when administered within 4.5 hours of ischemic stroke onset.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multicenter, prospective, randomized, open label, blinded-endpoint (PROBE),Parallel controls,Non-inferiority
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase Ⅲ, Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Injection Versus Alteplase for Acute Ischemic Stroke Within 4.5 Hours
Actual Study Start Date : March 31, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Arm Intervention/treatment
Active Comparator: rhTNK-tPA (0.25mg/kg)
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
Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.
Other Name: Recombinant Human TNK Tissue-type Plasminogen Activator for Injection

Active Comparator: rt-PA (0.9mg/kg)
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
Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.
Other Name: Alteplase injection (rt-PA)




Primary Outcome Measures :
  1. Modified Rankin Scale(mRS) [ Time Frame: 90 days ]
    Proportion of subjects with mRS(0-1) at 90 days.


Secondary Outcome Measures :
  1. Modified Rankin Scale(mRS) [ Time Frame: 90 days ]
    Proportion of subjects with mRS(0-2) at 90 days.

  2. National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 24 hours,day7 ]
    Proportion of subjects with NIHSS 0-1 at 24 hours and 7 days.

  3. EQ-5D [ Time Frame: 90 days ]
    Quality of life measured by EQ-5D scale.

  4. Barthel (BI) [ Time Frame: 90 days ]
    Global function of daily living defined as BI ≥ 95 at 90 days.

  5. Modified Rankin Scale(mRS) [ Time Frame: 90 days ]
    Ordinal distribution of mRS at 90 days.

  6. National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 24 hours,day7 ]
    Proportion of subjects with NIHSS score ≥ 4 improved compared with baseline at 24 hours and 7 days.


Other Outcome Measures:
  1. Symptomatic intracranial hemorrhage(sICH) [ Time Frame: 36 hours ]
    Proportion of subjects with symptomatic intracranial hemorrhage (sICH) at 36 hours.( defined by ECASSIII)

  2. Asymptomatic intracranial hemorrhage [ Time Frame: 90 days ]
    The incidence of asymptomatic intracranial hemorrhage at 90 days.

  3. PH2 intracranial hemorrhage [ Time Frame: 90 days ]
    The incidence of PH2 intracranial hemorrhage within 90 days (according to SITS standards).

  4. Any intracranial hemorrhage [ Time Frame: 90 days ]
    The incidence of any intracranial hemorrhage within 90 days.

  5. Systematic bleeding [ Time Frame: 90 days ]
    The incidence of Systematic bleeding at 90 days.( defined by GUSTO)

  6. Deaths [ Time Frame: 90 days ]
    Rate of Overall mortality at 90 days.

  7. AEs/SAEs [ Time Frame: 90 days ]
    The incidence of adverse events(AEs) / severe adverse events(SAEs) at 90 days.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04797013


Contacts
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Contact: YongJun Wang 13911172565 yongjunwang111@aliyun.com
Contact: ShuYa Li shuyali85@163.com

Locations
Show Show 61 study locations
Sponsors and Collaborators
Beijing Tiantan Hospital
Guangzhou Recomgen Biotech Co., Ltd.
Investigators
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Study Director: Wei Sun IRB of Beijing Tiantan Hospital,Capital Medical University
Publications of Results:
Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, van Walderveen MA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama à Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PL, van Rooij WJ, van den Berg JS, van Hasselt BA, Aerden LA, Dallinga RJ, Visser MC, Bot JC, Vroomen PC, Eshghi O, Schreuder TH, Heijboer RJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, Sprengers ME, Jenniskens SF, Beenen LF, van den Berg R, Koudstaal PJ, van Zwam WH, Roos YB, van der Lugt A, van Oostenbrugge RJ, Majoie CB, Dippel DW; MR CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015 Jan 1;372(1):11-20. doi: 10.1056/NEJMoa1411587. Epub 2014 Dec 17. Erratum in: N Engl J Med. 2015 Jan 22;372(4):394.

Other Publications:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yongjun Wang, President of Beijing Tiantan Hospital, Capital Medical University, Director of Neurology Center, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT04797013    
Other Study ID Numbers: MK02-2020-01
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yongjun Wang, Beijing Tiantan Hospital:
rhTNK-tPA
acute
stroke
phaseⅢ
Acute Ischemic Stroke
rt-PA
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Tissue Plasminogen Activator
Plasminogen
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action