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New hope for Late-Stroke patients: drug before procedure may boost recovery

NCT ID NCT06987305

Disease control Sponsor: Xinqiao Hospital of Chongqing Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving a clot-busting drug (rhTNK-tPA) before a clot-removal procedure helps stroke patients who arrive 4.5 to 24 hours after symptoms start. About 820 adults with a blocked large artery in the brain will receive either the drug or a placebo. The goal is to see if the drug improves blood flow and leads to better recovery at 90 days, while also checking for risks like bleeding in the brain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 820 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years; 2. Acute ischemic stroke presenting within 4.5-24 hours of last known well; 3. No significant pre-stroke functional disability: for age \<80 years, pre-stroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1; 4. Baseline NIHSS score ≥5; 5. Imaging criteria of BOTH: 1. Occlusion on CTA/MRA in one of the following vessels: M1/M2 segment of middle cerebral artery, A1 segment of anterior cerebral artery, V4 segment of vertebral artery, basilar artery, or P1 segment of posterior cerebral artery. For A1, or P1 occlusions, vessel diameter must be ≥0.75 mm; 2. For anterior circulation occlusion: CTP/MRP demonstrating mismatch ratio ≥1.8, absolute mismatch volume ≥15 mL, and ischemic core volume \<70 mL; OR have a mismatch between the presence of an abnormal signal on MRI diffusion-weighted imaging and no visible signal change on FLAIR. For posterior circulation occlusion: pc-ASPECTS score ≥6. 6. Plan to received endovascular thrombectomy; 7. The patient or their legal representative provides written informed consent. Exclusion Criteria: 1. Intracranial hemorrhage confirmed by CT/MRI; 2. Already received intravenous thrombolytic after index stroke.; 3. Pregnancy or lactation; 4. Concurrent participation in other investigation drug clinical trials; 5. Arterial tortuosity or other vascular anomalies precluding endovascular access to target vessel; 6. Pre-existing neurological/psychiatric disorders interfering with neurological assessment; 7. Space-occupying intracranial tumors (except small meningiomas ≤3 cm); 8. Intracranial aneurysm or arteriovenous malformation; 9. Terminal illness with life expectancy \<6 months; 10. Anticipated inability to complete follow-up assessments.

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Conditions

The condition(s) this trial relates to.

cerebral artery occlusion ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stroke, acute ischemic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jiujiang First People's Hospital

    RECRUITING

    Jiujiang, Jiangxi, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

  • Wuhan No. 1 Hospital

    RECRUITING

    Wuhan, Hubei, 430000, China

  • Xiangtan Central Hospital

    RECRUITING

    Xiangtan, Hunan, 421001, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.