Phase 3 Stroke Trial, Recruiting NCT07201688 Sponsor: CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd. Condition: Stroke
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Phase 3 Stroke Trial, Recruiting

NCT07201688
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, of any gender
  • People whose stroke symptoms began between 4.5 and 24 hours before treatment — this includes people who woke up with stroke symptoms or had a stroke with no one present to witness it; the starting time is counted from the last moment the person was known to be well
  • People who were largely independent before the stroke (a low disability score of 0 or 1 on a standard scale called the Modified Rankin Scale)
  • People with a stroke severity score of 6 or higher on a standard medical scale (called the NIHSS)
  • People whose brain scans (CT or MRI with specialised imaging) show a blockage in a specific brain artery, and whose scans show that a meaningful area of brain tissue is at risk but not yet permanently damaged — measured using specific size and ratio thresholds (confirm exact imaging requirements with trial site)
  • People (or their legal guardian) who are willing and able to sign a consent form to participate

Who may not be able to join:

  • People who have a known allergy to a clot-dissolving medication called recombinant human tissue plasminogen activator (rhTNK-tPA)
  • People whose life expectancy is estimated to be less than one year
  • People whose stroke symptoms are improving rapidly on their own, as judged by the medical team
  • People who are significantly unresponsive or unconscious (scoring above 2 on a specific part of the NIHSS consciousness assessment), or who had a seizure at the time of the stroke, or developed limb weakness following a seizure, or have another neurological or psychiatric condition that prevents them from cooperating
  • People with severely high blood pressure that cannot be controlled with medication
  • People with blood sugar levels that are very low (below 2.8 mmol/L) or very high (above 22.2 mmol/L)
  • People with active internal bleeding or a high risk of bleeding
  • People with any known blood clotting disorder
  • People with known problems with platelet function, or a platelet count below 100×10⁹/L (a measure of blood cells that help with clotting)

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: 031169085587

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

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
Registry
ClinicalTrials.gov
Start date
30 November 2025
Est. completion
30 September 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The proportion of participants with a score of 0-1 on the modified Rankin Scale (mRS)

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