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Early use of tirofiban after tenecteplase for acute ischemic stroke

Safety and Efficacy of Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke

Phase 3 Interventional Second Affiliated Hospital of Guangxi Medical University · NCT05604638

This test sees if giving the antiplatelet drug tirofiban soon after tenecteplase helps adults with acute ischemic stroke avoid reocclusion and improve recovery.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment348 (estimated)
Ages18 Years and up
SexAll
SponsorSecond Affiliated Hospital of Guangxi Medical University Academic / other
Locations38 sites (Chuzhou, Anhui and 37 other locations)
Trial IDNCT05604638 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) who received tenecteplase for acute ischemic stroke, have NIHSS ≥4, are within 4–24 hours after thrombolysis with defined stable/worsening/fluctuating neurological status, and have no evidence of intracranial hemorrhage may qualify.

Not a fit: Patients with confirmed intracranial hemorrhage, certain large-vessel occlusions or other major contraindications to antiplatelet therapy are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, early tirofiban could reduce post-thrombolysis reocclusion and improve functional recovery after acute ischemic stroke.

How similar studies have performed: Smaller studies and observational reports have suggested benefit from early antiplatelet or glycoprotein IIb/IIIa inhibitor use after reperfusion, but large randomized evidence in this specific tenecteplase-plus-tirofiban setting is limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Chuzhou, Anhui and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Ischemic Strokerandomized trialtenecteplasetirofibanintravenous thrombolysis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.