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Clinical Trial · English Editorial Summary

Beijing Tiantan Hospital: the TRACE-5 trial of tenecteplase for basilar artery occlusion

Edited by Wellward China · Sources checked 20 October 2026 · Reported 5 February 2026
Beijing Tiantan Hospital Beijing Brain & Nervous System Basilar artery occlusion Thrombolysis Clinical Trial
Source and editorial note: this is an original English summary written from the sources listed in the References below. It is not a full translation, and it is not an independent clinical assessment. The cited sources are the authority for the original account.

Quick answer

Basilar artery occlusion is the most lethal form of ischaemic stroke: without recanalisation, roughly 90% of patients are left disabled or die. Thrombectomy is the default when a patient reaches a centre that can do it, but many do not, and many arrive late. TRACE-5, led by Wang Yongjun at Beijing Tiantan Hospital across 66 Chinese centres, asked whether intravenous tenecteplase helps within 24 hours. It did: good functional outcome at 90 days rose from 28% to 37.6%, with no significant increase in mortality or symptomatic intracranial haemorrhage. The trial was published in The Lancet on 5 February 2026 [1][3][5].

Key takeaways

  • Design: multicentre, prospective, randomised, open-label, blinded-endpoint, superiority phase 3 trial at 66 Chinese stroke centres [2][5].
  • Population: 452 patients with basilar artery occlusion within 24 hours of onset or last known well, including wake-up and unwitnessed strokes [5].
  • Dose: tenecteplase 0.25 mg/kg to a maximum of 25 mg [5].
  • Primary outcome: 90-day mRS 0–1 or return to baseline in 37.6% versus 28% [5][6].
  • Safety: no significant difference in 90-day mortality or 36-hour symptomatic intracranial haemorrhage [3][6].

Why the control arm matters

Both arms could receive endovascular treatment, and the control arm was allowed to use alteplase where indicated. That design reflects real practice rather than a laboratory comparison: the question was whether adding tenecteplase before or instead of standard care improves outcomes, not whether thrombolysis beats placebo [3][4].

TRACE-5 trial of tenecteplase for basilar artery occlusion at Beijing Tiantan Hospital
Tenecteplase within 24 hours of basilar artery occlusion.

It also follows a programme. In 2024 the same group published TRACE-III in the New England Journal of Medicine, extending tenecteplase to 24 hours in anterior-circulation large-vessel occlusion. TRACE-5 extends the same question to the posterior circulation, where the risk of bleeding is different and the consequences of occlusion are more catastrophic [2].

Reading a 9.6-point gain

An absolute increase of roughly ten percentage points in independent function is substantial for a condition in which most patients are otherwise left severely disabled. The absence of excess mortality and haemorrhage is what makes the result usable, because posterior-circulation strokes carry a high bleeding risk when reperfused [3][5].

Open-label, and a focused population

Outcome assessors were blinded but treating clinicians were not, which is the accepted standard for thrombolysis trials but still a design limitation. The trial enrolled patients eligible for intravenous thrombolysis with pre-stroke mRS ≤3, so the frailest patients were excluded. Sample size of 452 across 66 centres means about seven patients per centre on average — a reminder that the result depends on protocol discipline rather than individual volume. Longer-term and quality-of-life data will follow [5][6].

The condition in context: basilar occlusion

Posterior-circulation stroke is less common than anterior but far more often fatal.

RegionWhat the data showsSource
Prognosis Without recanalisation, about 90% of patients are disabled or die [1][2]. Tiantan / Capital Medical University [1][2]
Prior evidence Late-window thrombolysis evidence for this territory was lacking before TRACE-5 [2]. Capital Medical University [2]
Guidelines Guidelines already suggest thrombolysis up to 24 hours in eligible patients without contraindications [4]. Tencent News / Lancet interview [4]

Because many basilar occlusions present with fluctuating symptoms and delayed diagnosis, an extended window has more practical relevance here than in anterior stroke [1][5].

Why it matters

PotentialWhat the report suggestsSource
New option Thrombolysis extended to 24 hours for basilar occlusion [2][5]. [2][5]
Effect size 37.6% versus 28% independent at 90 days [5]. [5]
Caution Open-label; selected population [6]. [6]

Availability and limits

  • This is an editorial summary of the publication, not a treatment recommendation [1][5].
  • Eligibility requires basilar occlusion confirmed on imaging within 24 hours [5].
  • Patients with pre-stroke disability above mRS 3 were excluded [5].
  • Open-label design; long-term functional data still maturing [6].
  • Access depends on a stroke centre able to image and treat urgently [1].

What to ask before booking

QuestionWhy it matters
Is the occlusion basilar, and how long since onset? Both determine eligibility for the 24-hour window [5].
Is thrombectomy available here? It remains the default where feasible [3].
Which department handles foreign patients, and in what language? Tiantan is a working hospital we do not book; confirm international-department coordination and language support.
What is my bleeding risk profile? Reperfusion in the posterior circulation carries specific risk [6].

Questions patients ask

What did TRACE-5 test?

Intravenous tenecteplase versus standard medical treatment within 24 hours of basilar artery occlusion, in a multicentre randomised phase 3 trial at 66 Chinese centres [2][5].

What was the result?

90-day independent outcome (mRS 0–1 or back to baseline) was 37.6% with tenecteplase versus 28% with standard treatment [5].

Was it safe?

No significant difference in 90-day mortality or 36-hour symptomatic intracranial haemorrhage [3][6].

Where was it published?

The Lancet, online 5 February 2026, and presented at the International Stroke Conference [1][2].

Is this relevant to international patients?

It is useful context for stroke care in China. Tiantan is a working hospital we do not book — contact its international department directly [1].