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New drug cocktail aims to boost stroke recovery in mild cases

NCT ID NCT07369999

Disease control Sponsor: Xiangya Hospital of Central South University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Updated 2 times

Summary

This study tests whether adding butylphthalide (a neuroprotective drug) to standard clot-busting tenecteplase helps people with mild but disabling stroke recover better. About 1,062 adults aged 18-80 who can be treated within 4.5 hours of symptoms will receive either the combo or tenecteplase alone. The main goal is to see if more patients are symptom-free at 90 days.

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 1,062 people

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

Started

Feb 2026

Expected to finish

Jun 2029

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 to 80 years

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 18-80 years, regardless of gender. * 2\. Clinically diagnosed with acute ischemic stroke and meets the criteria for tenecteplase intravenous thrombolysis. * 3\. Onset of the current stroke within 4.5 hours. * 4\. Clinical diagnosis of minor ischemic stroke with a NIHSS score of 2-5, accompanied by persistent unilateral limb weakness or speech symptoms, defined as a score ≥1 on either the language item or any one limb item of the NIHSS * 5\. Pre-stroke mRS score ≤1. * 6\. The subject or their legal representative is able and willing to sign the informed consent form. Exclusion Criteria: * 1\. History of intracranial hemorrhage. * 2\. Patients who have received or plan to undergo mechanical thrombectomy. * 3\. History of major head trauma or stroke within the past 3 months. * 4\. Known severe liver/kidney dysfunction or patients receiving dialysis (severe liver dysfunction: ALT/AST \>3 times the upper limit of normal; severe kidney dysfunction: serum creatinine \>3.0 mg/dl \[265.2 μmol/L\] or GFR \<30 ml/min/1.73 m²). * 5\. Systolic blood pressure \<90 mmHg or \>220 mmHg. * 6\. Patients with bradycardia (heart rate \<60 beats/min) or sick sinus syndrome. * 7\. History of drug/food allergy or known allergy to the components of the study drugs. * 8\. Patients treated with drugs containing butylphthalide after stroke onset. * 9\. History of congenital/acquired hemorrhagic diseases, coagulation factor deficiency, or thrombocytopenic diseases. * 10\. Pregnant or lactating subjects or subjects planning to become pregnant within 90 days. * 11\. Subjects with severe mental disorders or dementia who cannot cooperate with informed consent and follow-up. * 12\. Subjects with concurrent malignant tumors or severe systemic diseases, with an expected survival of \<90 days. * 13\. Patients who have participated in other clinical interventional studies within 30 days prior to randomization, or who are currently participating in other clinical interventional studies; * 14\. Patients who are unable to complete follow-up visits as scheduled; * 15\. Any other reasons that, in the investigator's opinion, render the patient unsuitable for participation in the study.

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

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

Mild disabling acute ischemic stroke

How to take part

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

  1. The places running it

    15 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

  • Cili County People's Hospital

    RECRUITING

    Cili, Hunan, China

  • Huayuan County People's Hospital

    RECRUITING

    Huayuan, Hunan, China

  • Lanshan Central Hospital

    RECRUITING

    Lanshan, Hunan, China

  • Leiyang People's Hospital

    RECRUITING

    Leiyang, Hunan, China

  • Linxiang People's Hospital

    RECRUITING

    Chang’an, Hunan, China

  • Liuyang Jili Hospital

    RECRUITING

    Guankou, Hunan, China

  • Ningxiang Hospital of Traditional Chinese Medicine

    RECRUITING

    Yutan, Hunan, China

  • Pingjiang First People's Hospital

    RECRUITING

    Pingjiang, Hunan, China

  • Shaodong People's Hospital

    RECRUITING

    Shaodong, Hunan, China

  • The Central Hospital of Xiangtan, The Affiliated Hospital of Hunan University

    RECRUITING

    Xiangtan, Hunan, 410008, China

  • The Central Hospital of Yongzhou

    RECRUITING

    Yongzhou, Hunan, 410008, China

  • The Third Hospital of Yiyang

    RECRUITING

    Yiyang, Hunan, China

  • Xiangya Hospital, Central South University

    RECRUITING

    Changsha, Hunan, 410600, China

  • Yizhang County People's Hospital

    RECRUITING

    Yizhang Chengguanzhen, Hunan, China

  • Yuanling County People's Hospital

    RECRUITING

    Yuanling, Hunan, China