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

Primary Purpose

Stroke, Acute, Stroke, Ischemic

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
rhTNK-tPA
Endovascular treatment
Sponsored by
Xinqiao Hospital of Chongqing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Thrombolysis, Endovascular treatment, rhTNK-tPA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Xinqiao Hospital of Army Medical UniversityRecruiting
  • Maoming Traditional Chinese Medicine Hospital
  • Wuhan No. 1 HospitalRecruiting
  • The 904th Hospital of CPLARecruiting
  • The First Affiliated Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conbined treatment group

Endovascular treatment alone group

Arm Description

intravenous tenecteplase bridging with endovascular treatment

endovascular treatment alone

Outcomes

Primary Outcome Measures

modified Rankin scale score
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)
excellent outcome
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days
functional independence
Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3)
ambulatory or bodily needs-capable or better
Substantial reperfusion at initial angiogram
evaluate effect of tenecteplase on reperfusion
Revascularization rates at 48 hours from randomization
evaluate vascular patency after treatment
Early neurologic improvement
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)
Health-related quality of life
Symptomatic/Asymptomatic intracranial hemorrhage within 48 hours
evaluate intracranial hemorrhage
Mortality within 90 days
evaluate death rate of the two treatment groups
Parenchymal hematoma
evaluate intracranial hemorrhage
Procedural-related complications and severe adverse events
evaluate complications and any adverse events

Full Information

First Posted
January 26, 2021
Last Updated
October 15, 2022
Sponsor
Xinqiao Hospital of Chongqing
Collaborators
CSPC RECOMGEN PHARMACEUTICAL (GUANGZHOU) CO.,LTD
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1. Study Identification

Unique Protocol Identification Number
NCT04733742
Brief Title
Endovascular Treatment With Versus Without Intravenous rhTNK-tPA in Stroke
Acronym
BRIDGE-TNK
Official Title
Intravenous rhTNK-tPA Bridging With Endovascular Treatment Versus Endovascular Treatment Alone For Stroke Patient With Large Vessel Occlusion: A Multicenter, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
March 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinqiao Hospital of Chongqing
Collaborators
CSPC RECOMGEN PHARMACEUTICAL (GUANGZHOU) CO.,LTD

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to investigate whether intravenous rhTNK-tPA 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.
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 rhTNK-tPA 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Stroke, Ischemic
Keywords
Thrombolysis, Endovascular treatment, rhTNK-tPA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
498 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conbined treatment group
Arm Type
Experimental
Arm Description
intravenous tenecteplase bridging with endovascular treatment
Arm Title
Endovascular treatment alone group
Arm Type
Active Comparator
Arm Description
endovascular treatment alone
Intervention Type
Drug
Intervention Name(s)
rhTNK-tPA
Other Intervention Name(s)
TNKase, TNK-tPA
Intervention Description
intravenous thrombolysis with rhTNK-tPA followed by endovascular treatment
Intervention Type
Other
Intervention Name(s)
Endovascular treatment
Other Intervention Name(s)
intra-arterial treatment, interventional therapy
Intervention Description
endovascular treatment
Primary Outcome Measure Information:
Title
modified Rankin scale score
Description
disability level
Time Frame
90 days
Secondary Outcome Measure Information:
Title
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)
Description
excellent outcome
Time Frame
90 days
Title
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days
Description
functional independence
Time Frame
90 days
Title
Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3)
Description
ambulatory or bodily needs-capable or better
Time Frame
90 days
Title
Substantial reperfusion at initial angiogram
Description
evaluate effect of tenecteplase on reperfusion
Time Frame
within 5 minutes at initial angiogram
Title
Revascularization rates at 48 hours from randomization
Description
evaluate vascular patency after treatment
Time Frame
at 48 hours from randomization
Title
Early neurologic improvement
Description
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
Time Frame
72 hours
Title
Health-related quality of life, assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L)
Description
Health-related quality of life
Time Frame
90 days
Title
Symptomatic/Asymptomatic intracranial hemorrhage within 48 hours
Description
evaluate intracranial hemorrhage
Time Frame
within 48 hours after endovascular treatment
Title
Mortality within 90 days
Description
evaluate death rate of the two treatment groups
Time Frame
90 days
Title
Parenchymal hematoma
Description
evaluate intracranial hemorrhage
Time Frame
within 48 hours after endovascular treatment
Title
Procedural-related complications and severe adverse events
Description
evaluate complications and any adverse events
Time Frame
within 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongming Qiu, MD
Phone
+8613236599269
Email
qiuzhongmingdoctor@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fengli Li, MD
Phone
+8617358339092
Email
lifengli01@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingwu Yang, MD
Organizational Affiliation
Neurology, Xinqiao Hospital of the Army Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raul G Nogueira, MD
Organizational Affiliation
Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey L Saver, MD
Organizational Affiliation
Neurology, University of California, Los Angeles, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wenjie Zi, MD
Organizational Affiliation
Neurology, Xinqiao Hospital of the Army Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinqiao Hospital of Army Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjie Zi, MD
Phone
+8618523033816
Email
ziwenjie1981@163.com
First Name & Middle Initial & Last Name & Degree
Zhongming Qiu
Phone
+8613236599269
Email
qiuzhongmingdoctor@163.com
Facility Name
Maoming Traditional Chinese Medicine Hospital
City
Maoming
State/Province
Guangdong
ZIP/Postal Code
525000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenguo Huang, MS
Phone
8613929795299
Email
13929795299@139.com
Facility Name
Wuhan No. 1 Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhua Liu, MD
Phone
8618871588816
Email
leeoowh@yeah.net
Facility Name
The 904th Hospital of CPLA
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhonghua Shi, MD
Phone
8618921150310
Email
18921150310@189.cn
Facility Name
The First Affiliated Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shouchun Wang, MD
Phone
8613596060906
Email
wangsc13@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
study data without patient information
IPD Sharing Time Frame
Related papers published 3 months later, the IPD will be shared.
IPD Sharing Access Criteria
yangqwmlys@163.com ziwenjie1981@163.com
Citations:
PubMed Identifier
32078683
Citation
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 Mar 8;327(10):985.
Results Reference
background
PubMed Identifier
30128510
Citation
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. No abstract available.
Results Reference
background
PubMed Identifier
29694815
Citation
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.
Results Reference
background
PubMed Identifier
33464335
Citation
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.
Results Reference
result

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Endovascular Treatment With Versus Without Intravenous rhTNK-tPA in Stroke

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