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
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xinqiao Hospital of Army Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| The First Affiliated Hospital, Hengyang Medical School, University of South China Coordinator of this site? Confirm its status | Hengyang | China | Unknown status |
| The Second Hospital of Jiaozuo Coordinator of this site? Confirm its status | Jiaozuo | China | Unknown status |
| Wuhan NO.1 Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The 904th Hospital of CPLA Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| Xiangtan Central Hospital Coordinator of this site? Confirm its status | Xiangtan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.