Tenecteplase or Reteplase Bridging Before Thrombectomy in Acute Ischemic Stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

TRACE-BRIDGE is a phase 3, multicenter, randomized trial with blinded outcome assessment. Adults with acute ischemic stroke within 4.5 hours of onset and anterior circulation large vessel occlusion are assigned to three groups: tenecteplase plus thrombectomy, reteplase plus thrombectomy, or direct thrombectomy. The study uses a PROBE design to compare safety and efficacy of bridging thrombolysis versus no thrombolysis before mechanical intervention. Primary outcomes focus on functional recovery and safety endpoints. Enrollment targets are set at multiple centers to evaluate whether bridging therapy improves outcomes over direct thrombectomy.

Why it matters

Who can join: the full rules

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

Where it's running

• Beijing Tiantan Hospital, Capital Medical Universiity
  Beijing, Beijing Municipality, China Recruiting
• Zhongnan Hospital of Wuhan University
  Wuhan, Hubei, China Not yet recruiting
• Xiangtan Central Hospital
  Xiangtan, Hunan, China Not yet recruiting
• Rizhao Hospital of Traditional Chinese Medicine
  Rizhao, Shandong, China Not yet recruiting
• Ya'an People's Hospital
  Ya'an, Sichuan, China Not yet recruiting

Study contacts

• Principal investigator: Yongjun Wang — Beijing Tiantan Hospital
• Study coordinator: Yongjun Wang, MD
• Email: yongjunwang@ncrcnd.org.cn
• Phone: +86 13911172565

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.