Butylphthalide plus Tenecteplase for mild disabling acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

BENEFIT-2 is a multicenter, randomized, double-blind study comparing two treatment strategies in adults with mild disabling AIS treated with IV tenecteplase within 4.5 hours. Participants are randomly assigned to receive tenecteplase plus butylphthalide or tenecteplase plus placebo, with stratified block randomization. The study aims to determine if the combination improves functional outcomes compared with TNK alone. Eligible patients have NIHSS scores 2-5, pre-stroke mRS ≤1, and meet thrombolysis criteria; key exclusions include prior intracranial hemorrhage and recent major stroke or head trauma. Outcomes will inform whether adding butylphthalide offers additional neuroprotection and functional benefit after thrombolysis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Xiangya Hospital, Central South University
  Changsha, Hunan, China Recruiting
• Linxiang People's Hospital
  Chang’an, Hunan, China Recruiting
• Cili County People's Hospital
  Cili, Hunan, China Recruiting
• Liuyang Jili Hospital
  Guankou, Hunan, China Recruiting
• Huayuan County People's Hospital
  Huayuan, Hunan, China Recruiting
• Lanshan Central Hospital
  Lanshan, Hunan, China Recruiting

Study contacts

• Study coordinator: Qiaoling Tang, MD
• Email: 228111051@csu.edu.cn
• Phone: 18867408758

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.