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Tenecteplase or Reteplase as Bridging Thrombolysis Before Thrombectomy in Acute Ischemic Cerebrovascular Events

RecruitingPhase 3Ages 18 Years - anyAllYongjun Wang
NCT07748039 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Acute ischemic stroke caused by large vessel occlusion (LVO) is a major cause of disability, and mechanical thrombectomy (MT) has become the standard treatment for eligible patients. However, the optimal role of intravenous thrombolysis before MT remains uncertain. The TRACE-BRIDGE trial is a phase 3, investigator-initiated, multicenter, randomized, open-label trial with blinded outcome assessment (PROBE design) evaluating different bridging thrombolysis strategies before MT. The trial will enroll adults with acute ischemic stroke presenting within 4.5 hours of symptom onset and with imaging-confirmed anterior circulation LVO who are eligible for intravenous thrombolysis and MT. Participants will be randomly assigned in a 1:1:1 ratio to receive tenecteplase plus MT, reteplase plus MT, or direct MT alone. The TRACE-BRIDGE trial aims to evaluate the efficacy and safety of bridging thromb

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients with acute ischemic stroke presenting within 4.5 hours of symptom onset who are eligible for intravenous thrombolytic therapy. A baseline non-contrast CT or MRI is required for screening. 2. Large vessel occlusion on computed tomographic angiography (CTA) or magnetic resonance angiography (MRA) of the intracranial carotid artery (ICA) or middle cerebral artery (MCA) M1 3. Age ⩾ 18 years at the time of signing the informed consent form 4. ASPECTS 6-10 5. Informed consent from the patients or their legal representative. Exclusion Criteria: 1. Intracranial hemorrhage (ICH) identified by CT or MRI 2. Rapidly improving symptoms at the discretion of the investigator 3. mRS \> 2 before stroke onset. 4. Massive cerebral infarction (infarct size greater than one-third of the blood middle cerebral artery supply area) suggested by CT. 5. Known contraindication to imaging with contrast agents 6. Planned adjunct intra-arterial (IA) thrombolysis during or after endovascular treatment (EVT). 7. Secondary transfer from a primary stroke center 8. Any terminal illness such that patient would not be expected to survive more than one year 9. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study 10. Pregnant women
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What it tests

  • rhTNK-tPA (0.25mg/kg)
  • Reteplase 10 Units (U) plus a second dose of reteplase 10 U
  • No thrombolysis (thrombectomy alone)
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Where

5 sites
Beijing Tiantan Hospital, Capital Medical Universiity
Beijing, China
Zhongnan Hospital of Wuhan University
Wuhan, China
Xiangtan Central Hospital
Xiangtan, China
Rizhao Hospital of Traditional Chinese Medicine
Rizhao, China
Ya'an People's Hospital
Ya'an, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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