Early use of tirofiban after tenecteplase for 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

This is a randomized Phase 3 trial comparing early intravenous tirofiban versus placebo in patients who have received tenecteplase for acute ischemic stroke. Eligible adults (NIHSS ≥4) are enrolled within 4–24 hours after tenecteplase if they meet prespecified patterns of stable, worsening, or fluctuating neurological status and have no intracranial hemorrhage. Participants receive either tirofiban hydrochloride or placebo and are followed for safety and clinical outcomes, with particular attention to reocclusion and hemorrhagic complications. The trial is conducted at several hospitals in China under the sponsorship of the Second Affiliated Hospital of Guangxi Medical University.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years old;
2. Within 4-24 hours after intravenous thrombolytic therapy with tenerplase for acute ischemic stroke, there was no significant change in symptoms compared to the baseline (defined as an increase or decrease of 0 or 1 point in the NIHSS score), and neurological function deteriorated (defined as an increase of ≥ 2 in the NIHSS score compared to the baseline) Fluctuations in neurological function (defined as an increase of 4 points or more in the NIHSS score compared to the baseline and then a decrease of 4 points or more);
3. NIHSS ≥ 4 points before randomization;
4. The patient or their family members sign a written informed consent form.

Exclusion Criteria:

1. Intracranial hemorrhage was confirmed by CT or MRI after intravenous thrombolysis and before randomization;
2. CTA/MRA/DSA showed occlusion of the internal carotid artery, middle cerebral artery M1, M2 or M3 segment, anterior cerebral artery A1, A2 or A3 segment, posterior cerebral artery P1, P2 or P3, vertebral or basilar artery;
3. Confirmed or suspected cardioembolic stroke mechanisms, including any of the following: documented cardiac sources of thromboembolism: chronic or paroxysmal atrial fibrillation, rheumatic mitral stenosis, prosthetic heart valves, infective endocarditis, intracardiac thrombus or implanted prosthetic material, dilated cardiomyopathy (left ventricular ejection fraction \<40%), or spontaneous echo contrast in the left atrium; other laboratory-confirmed embolic sources: patent foramen ovale with concomitant atrial septal aneurysm, or cryptogenic stroke with a CHADS-VASC score ≥ 2 indicating high thromboembolic risk;
4. Blood platelet count was lower than 100×10\^9/L;
5. Renal insufficiency, glomerular filtration rate \< 30 mL/min;
6. Pregnant or lactating women;
7. Allergic to tirofiban, nickel, titanium or their alloys;
8. Prior neurological or psychiatric illness that prevents assessment of neurological function;
9. Pre-existing bleeding disease, severe heart, liver, or kidney disease, or sepsis;
10. Brain tumors with a space-occupying effect on imaging (other than micromeningiomas);
11. Intracranial aneurysm, arteriovenous malformation;
12. Life expectancy of any advanced disease \< 6 months;
13. Participating in other clinical trials.

Where it's running

• Mingguang People's Hospital
  Chuzhou, Anhui, China Recruiting
• Longyan People´s Hospital, Longyan City
  Longyan, Fujian, China Recruiting
• The Second Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Recruiting
• Huangmei People's Hospital
  Huanggang, Hubei, China Recruiting
• Yiling People's Hospital of Yichang city
  Yichang, Hubei, China Recruiting
• Hunan Xupu Chengnan Hospital
  Huaihua, Hunan, China Recruiting

Study contacts

• Principal investigator: Zhongming Qiu, MD — Sun Yet-sen University
• Study coordinator: Deyan Kong, MD
• Email: kongdeyangxnn@163.com
• Phone: +8618376635080

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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.