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NCT04733742CompletedPhase 2/3

Endovascular Treatment With Versus Without Intravenous rhTNK-tPA in Stroke

Intravenous rhTNK-tPA Bridging With Endovascular Treatment Versus Endovascular Treatment Alone For Stroke Patient With Large Vessel Occlusion: A Multicenter, Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 3 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
550 (actual)
First submitted
26 Jan 2021
Start date
9 May 2022
Primary completion date
16 Dec 2024
Lead sponsor
Xinqiao Hospital of Chongqing
Diseases
Stroke
NCT number
NCT04733742

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 550
  • From 9 May 2022 to the primary completion date, 16 Dec 2024
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Already received intravenous thrombolytic after index stroke
  • Current participation in another investigational drug clinical trial

Other illness

  • Intracranial hemorrhage on baseline CT or MR
  • Arterial tortuosity and/or other arterial disease that would lead to unstable access platform or prevent the thrombectomy device from reaching the target vessel
  • Patient with a preexisting neurological or psychiatric disease that would confound the outcome assessments
  • Any terminal disease with a life expectancy less than half a year

Lab values

  • Known pregnancy, or breastfeeding, or serum beta human chorionic gonadotropin test is positive on admission

Other

  • Contraindication to intravenous thrombolytics
  • Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys
  • Patient with occlusions in two or more vascular territories (e.g. bilateral territories, or anterior and posterior circulation)
  • Mass effect or intracranial neoplasm on baseline CT or MR (except small meningioma)
  • Intracranial arteriovenous malformation or aneurysm on baseline CT or MR angiography
  • Unlikely to be available for follow-up at 90 days.

Who the study is looking for

  • Aged 18 years or older;
  • Patient with acute ischemic stroke who is eligible for intravenous thrombolysis treatment within 4.5 hours of time last known well;
  • No significant prestroke functional disability: for age \<80 years, prestroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1;
  • MCA-M1 or -M2, basilar artery, or posterior cerebral artery-P1 occlusion proved by CTA/MRA;
  • EVT is planned by clinical care team;
  • Written informed consent is obtained from patients and/or their legal representatives.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Xinqiao Hospital of Army Medical University
Coordinator of this site? Confirm its status
ChongqingChinaUnknown status
The First Affiliated Hospital, Hengyang Medical School, University of South China
Coordinator of this site? Confirm its status
HengyangChinaUnknown status
The Second Hospital of Jiaozuo
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JiaozuoChinaUnknown status
Wuhan NO.1 Hospital
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
The 904th Hospital of CPLA
Coordinator of this site? Confirm its status
WuxiChinaUnknown status
Xiangtan Central Hospital
Coordinator of this site? Confirm its status
XiangtanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.