Endovascular Treatment With Versus Without Intravenous Tenecteplase in Stroke (BRIDGE-TNK)

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ClinicalTrials.gov Identifier: NCT04733742

Recruitment Status : Not yet recruiting

First Posted : February 2, 2021

Last Update Posted : February 4, 2022

See Contacts and Locations

Sponsor:

Collaborators:

Wuhan No. 1 Hospital (Wenhua Liu)

The 904th Hospital of PLA (Zhonghua Shi)

The First Affiliated Hospital of Jilin University (Shouchun Wang)

Maoming Traditional Chinese Medicine Hospital (Wenguo Huang)

Information provided by (Responsible Party):

Zhongming Qiu, Xinqiao Hospital of Chongqing

Study Description

Brief Summary:

The purpose of this trial is to investigate whether intravenous tenecteplase prior to endovascular treatment can improve 90-day functional outcome of stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of symptom onset.

Condition or disease	Intervention/treatment	Phase
Stroke, Acute Stroke, Ischemic	Drug: Tenecteplase Other: Endovascular treatment	Phase 2 Phase 3

Detailed Description:

The DEVT, SKIP and DIRECT-MT trials showed that endovascular treatment alone is not inferior to intravenous alteplase bridging with endovascular treatment in terms of achieving 90-day functional independence for stroke patients with large vessel occlusion. The EXTEND-IA TNK part 1 and part 2 demonstrated that intravenous thrombolysis with tenecteplase is superior to alteplase before endovascular treatment. However, it is unclear whether intravenous tenecteplase bridging with endovascular treatment is superior to endovascular treatment alone. The purpose of this trial is to investigate whether intravenous tenecteplase bridging with endovascular treatment is better than endovascular treatment alone for stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of onset.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	586 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Intravenous Tenecteplase Bridging With Endovascular Treatment Versus Endovascular Treatment Alone For Stroke Patient With Large Vessel Occlusion: A Multicenter, Double-Blind, Randomized Controlled Trial
Estimated Study Start Date :	April 1, 2022
Estimated Primary Completion Date :	December 1, 2025
Estimated Study Completion Date :	April 1, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Tenecteplase

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Conbined treatment group intravenous tenecteplase bridging with endovascular treatment	Drug: Tenecteplase intravenous thrombolysis with tenecteplase followed by endovascular treatment Other Names: TNKase Metalyse TNK-tPA Other: Endovascular treatment endovascular treatment Other Names: intra-arterial treatment interventional therapy
Active Comparator: Endovascular treatment alone group endovascular treatment alone	Other: Endovascular treatment endovascular treatment Other Names: intra-arterial treatment interventional therapy

Outcome Measures

Primary Outcome Measures :

modified Rankin scale score [ Time Frame: 90 days ]
disability level

Secondary Outcome Measures :

Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1) [ Time Frame: 90 days ]
excellent outcome
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days [ Time Frame: 90 days ]
functional independence
Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3) [ Time Frame: 90 days ]
ambulatory or bodily needs-capable or better
Substantial reperfusion at initial angiogram [ Time Frame: within 5 minutes at initial angiogram ]
evaluate effect of tenecteplase on reperfusion
Revascularization rates at 48 hours from randomization [ Time Frame: at 48 hours from randomization ]
evaluate vascular patency after treatment
Early neurologic improvement [ Time Frame: 72 hours ]
Early neurologic improvement was defined as a reduction of 8 points in the NIHSS score between baseline and 72 hours or as a score of 0 or 1 at 72 hours. An 8-point reduction is considered to be highly clinically significant
Health-related quality of life, assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L) [ Time Frame: 90 days ]
Health-related quality of life
Symptomatic/Asymptomatic intracranial hemorrhage within 48 hours [ Time Frame: within 48 hours after endovascular treatment ]
evaluate intracranial hemorrhage
Mortality within 90 days [ Time Frame: 90 days ]
evaluate death rate of the two treatment groups
Parenchymal hematoma [ Time Frame: within 48 hours after endovascular treatment ]
evaluate intracranial hemorrhage
Procedural-related complications and severe adverse events [ Time Frame: within 90 days ]
evaluate complications and any adverse events

Eligibility Criteria

Information from the National Library of Medicine

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

Criteria

Inclusion Criteria:

Aged 18 years or older;
Acute ischemic stroke confirmed by clinical symptoms or imaging examination;
MCA-M1 or -M2, basilar artery, or posterior cerebral artery-P1 occlusion proved by CTA/MRA;
Eligible for intravenous thrombolysis with TNK-tPA;
Time from stroke onset to randomization within 4.25 hours;
Written informed consent is obtained from patients and/or their legal representatives.

Exclusion Criteria:

CT or MR evidence of intracranial hemorrhage;
Contraindications of intravenous thrombolysis;
Currently in pregnant or lactating or serum beta HCG test is positive on admission;
Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys;
Current participation in another clinical trial
Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
Patients with occlusions in multiple vascular territories (e.g. bilateral anterior circulation, or anterior/posterior circulation);
CT or MR evidence of mass effect or intracranial tumor (except small meningioma);
CT or MR angiography evidence of intracranial arteriovenous malformations or aneurysms;
Any terminal illness with life expectancy less than 6 months;
Unlikely to be available for 90-day follow-up.

Contacts and Locations

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): NCT04733742

Contacts

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Contact: Zhongming Qiu, MD	+8613236599269	qiuzhongmingdoctor@163.com
Contact: Fengli Li, MD	+8617358339092	lifengli01@yeah.net

Locations

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China, Chongqing
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing, China, 400037
Contact: Wenjie Zi, MD +8618523033816 ziwenjie1981@163.com
Contact: Zhongming Qiu +8613236599269 qiuzhongmingdoctor@163.com
China, Guangdong
Maoming Traditional Chinese Medicine Hospital
Maoming, Guangdong, China, 525000
Contact: Wenguo Huang, MS 8613929795299 13929795299@139.com
China, Hubei
Wuhan No. 1 Hospital
Wuhan, Hubei, China, 430000
Contact: Wenhua Liu, MD 8618871588816 leeoowh@yeah.net
China, Jiangsu
The 904th Hospital of CPLA
Wuxi, Jiangsu, China, 214000
Contact: Zhonghua Shi, MD 8618921150310 18921150310@189.cn
China, Jilin
The First Affiliated Hospital of Jilin University
Changchun, Jilin, China, 130000
Contact: Shouchun Wang, MD 8613596060906 wangsc13@163.com

Sponsors and Collaborators

Xinqiao Hospital of Chongqing

Wuhan No. 1 Hospital (Wenhua Liu)

The 904th Hospital of PLA (Zhonghua Shi)

The First Affiliated Hospital of Jilin University (Shouchun Wang)

Maoming Traditional Chinese Medicine Hospital (Wenguo Huang)

Investigators

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Principal Investigator:	Qingwu Yang, MD	Neurology, Xinqiao Hospital of the Army Medical University
Principal Investigator:	Raul G Nogueira, MD	Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, USA
Principal Investigator:	Jeffrey L Saver, MD	Neurology, University of California, Los Angeles, USA
Principal Investigator:	Wenjie Zi, MD	Neurology, Xinqiao Hospital of the Army Medical University

More Information

Publications of Results:

Zi W, Qiu Z, Li F, Sang H, Wu D, Luo W, Liu S, Yuan J, Song J, Shi Z, Huang W, Zhang M, Liu W, Guo Z, Qiu T, Shi Q, Zhou P, Wang L, Fu X, Liu S, Yang S, Zhang S, Zhou Z, Huang X, Wang Y, Luo J, Bai Y, Zhang M, Wu Y, Zeng G, Wan Y, Wen C, Wen H, Ling W, Chen Z, Peng M, Ai Z, Guo F, Li H, Guo J, Guan H, Wang Z, Liu Y, Pu J, Wang Z, Liu H, Chen L, Huang J, Yang G, Gong Z, Shuai J, Nogueira RG, Yang Q; DEVT Trial Investigators. Effect of Endovascular Treatment Alone vs Intravenous Alteplase Plus Endovascular Treatment on Functional Independence in Patients With Acute Ischemic Stroke: The DEVT Randomized Clinical Trial. JAMA. 2021 Jan 19;325(3):234-243. doi: 10.1001/jama.2020.23523.

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. Erratum in: JAMA. 2022 Feb 14;:.

Mai LM, Oczkowski W. Tenecteplase before thrombectomy for ischemic stroke improved reperfusion compared with alteplase. Ann Intern Med. 2018 Aug 21;169(4):JC20. doi: 10.7326/ACPJC-2018-169-4-020.

Campbell BCV, Mitchell PJ, Churilov L, Yassi N, Kleinig TJ, Dowling RJ, Yan B, Bush SJ, Dewey HM, Thijs V, Scroop R, Simpson M, Brooks M, Asadi H, Wu TY, Shah DG, Wijeratne T, Ang T, Miteff F, Levi CR, Rodrigues E, Zhao H, Salvaris P, Garcia-Esperon C, Bailey P, Rice H, de Villiers L, Brown H, Redmond K, Leggett D, Fink JN, Collecutt W, Wong AA, Muller C, Coulthard A, Mitchell K, Clouston J, Mahady K, Field D, Ma H, Phan TG, Chong W, Chandra RV, Slater LA, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Bladin CF, Sharma G, Desmond PM, Parsons MW, Donnan GA, Davis SM; EXTEND-IA TNK Investigators. Tenecteplase versus Alteplase before Thrombectomy for Ischemic Stroke. N Engl J Med. 2018 Apr 26;378(17):1573-1582. doi: 10.1056/NEJMoa1716405.

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Responsible Party:	Zhongming Qiu, Professor, Xinqiao Hospital of Chongqing
ClinicalTrials.gov Identifier:	NCT04733742
Other Study ID Numbers:	BRIDGE-TNK
First Posted:	February 2, 2021 Key Record Dates
Last Update Posted:	February 4, 2022
Last Verified:	February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	study data without patient information
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Analytic Code
Time Frame:	Related papers published 3 months later, the IPD will be shared.
Access Criteria:	yangqwmlys@163.com ziwenjie1981@163.com

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

Keywords provided by Zhongming Qiu, Xinqiao Hospital of Chongqing:


Thrombolysis Endovascular treatment Tenecteplase

Additional relevant MeSH terms:

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Stroke Ischemic Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases	Vascular Diseases Cardiovascular Diseases Tenecteplase Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action

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