Phase 3 Stroke Trial, Recruiting NCT06954155 Sponsor: Beijing Tiantan Hospital Condition: Stroke
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Phase 3 Stroke Trial, Recruiting

NCT06954155
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older
  • People who had an acute ischemic stroke (a stroke caused by a blocked blood vessel) with symptoms starting between 24 and 72 hours before joining the trial — including strokes noticed upon waking or strokes with an unknown exact start time, where "start time" means the last time the person was known to be well
  • People who were largely independent before their stroke (with little to no disability beforehand, as measured by a standard scale)
  • People with a moderate to severe stroke score on a standard neurological assessment scale, or a slightly lower score if the stroke has caused a significant disability such as vision loss on one side, speech difficulty, or loss of hand function
  • People whose brain scans (using CT or MRI with blood vessel imaging) show a blockage in a specific artery — in the middle, front, or back of the brain, or in the basilar artery — that explains the stroke symptoms
  • People whose brain scans show a pattern where only a limited area of brain tissue has been permanently damaged, but a larger surrounding area may still be rescued (confirm with trial site for specific technical thresholds)
  • People (or their legally authorised representatives) who are able to provide written consent to participate

Who may not be able to join:

  • People whose CT brain scan already shows a large area of established damage
  • People with a known allergy to the study drug, tenecteplase
  • People whose stroke symptoms are improving rapidly, in the opinion of the treating doctor
  • People who are very difficult to rouse or communicate with, have had a recent epileptic seizure, or have another neurological or mental health condition that prevents cooperation with the trial
  • People with persistently very high blood pressure (systolic at or above 185 mmHg or diastolic at or above 110 mmHg) even after blood pressure-lowering treatment
  • People with very low or very high blood sugar levels at the time of assessment
  • People with active internal bleeding, or those considered at high risk of bleeding — for example, those who had major surgery, a significant injury, or bleeding in the gut or urinary tract within the past 21 days, or a needle inserted into a blood vessel in a location where pressure cannot be applied within the past 7 days
  • People with known problems with blood clotting due to a medical condition or blood-thinning medication use — including specific situations involving warfarin, newer blood-thinning tablets, heparin, or similar medicines (confirm with trial site for specific details)
  • People with known platelet function problems or a very low platelet count (below 100,000/mm³) — note that people taking antiplatelet medicines such as aspirin may still be eligible (confirm with trial site)
  • People who have had an ischemic stroke or heart attack in the past 3 months, a previous bleed inside the brain, a severe head injury, brain or spinal surgery in the past 3 months, or a known brain tumour, abnormal blood vessel tangle in the brain, or very large brain aneurysm
  • People with a serious terminal illness where survival beyond one year would not be expected
  • People for whom the required specialised brain imaging tests cannot be performed
  • People whose brain scans show damage already covering more than one-third of the middle cerebral artery territory, or a low score on a specific scale used for basilar artery strokes (confirm with trial site)
  • People whose CT or MRI scan shows any current or past bleeding inside the brain
  • People with blockages in more than one major brain artery at the same time
  • Women who are pregnant, breastfeeding, or unwilling to use effective contraception during the trial period
  • People who are unlikely to be able to follow the trial procedures or attend follow-up visits
  • People with any other condition that the treating doctor believes could make participation unsafe or interfere with the trial
  • People who have participated in another interventional clinical trial within the past 3 months

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 86-10-59978350

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Beijing Tiantan Hospital
Registry
ClinicalTrials.gov
Start date
30 May 2025
Est. completion
28 February 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

mRS score ≤ 1 at 90 days

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov