Using tirofiban after successful vessel reopening in acute ischemic stroke

Safety and Efficacy of Adjunct Tirofiban Treatment After Successful Mechanical Thrombectomy Recanalization in Acute Anterior Circulation Ischemic Stroke- A Multicenter, Prospective, Double-blind, Randomized Trial

This study is testing if giving tirofiban after a successful stroke procedure can help patients recover better by preventing blood vessels from getting blocked again.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 1360 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tongji Hospital (other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06265051 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of tirofiban therapy administered after successful mechanical thrombectomy in patients with acute ischemic stroke caused by large vessel occlusion. The study is a multicenter, prospective, double-blind, randomized controlled trial that aims to determine if tirofiban can improve outcomes by preventing vascular reocclusion and enhancing microcirculation perfusion. Participants will be monitored for 90 days to assess the impact of tirofiban on prognosis following the procedure.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have experienced an acute ischemic stroke with specific occlusion sites and have undergone successful mechanical thrombectomy.

Not a fit: Patients who have received intra-arterial thrombolysis or have used tirofiban within 24 hours prior to the procedure may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients who have undergone mechanical thrombectomy for acute ischemic stroke.

How similar studies have performed: While the use of tirofiban in stroke treatment is established, this specific approach following mechanical thrombectomy is novel and lacks extensive prior evidence.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years old;
2. NIHSS score: 6-30;
3. Symptom onset to random time of 24h, including wake-up stroke or unwitnessed stroke; The onset time of symptoms was defined as the last time of normal performance.
4. mRS 0-1 before the stroke;
5. Subject or legal representative can sign an informed consent form;
6. Clinical symptoms caused by acute occlusion of the following sites confirmed by CTA or MRA: intracranial segment of ICA, M1 segment of middle cerebral artery, M2 trunk of middle cerebral artery;
7. ASPECTS≥6 on NCCT or DWI;
8. After the end of mechanical thrombectomy, the mTICI was stable at 2b/3, and there was no secondary embolism in other non-offending vessels, or the diagnostic angiography before mechanical thrombectomy showed that the occluded vessels improved to mTICI 2b/3, and no mechanical thrombectomy was planned.

Exclusion Criteria:

1. Intra-arterial thrombolysis;
2. Tirofiban was used within 24 hours before endovascular treatment
3. Women who are known to be pregnant or lactating, or have a positive pregnancy test before randomization;
4. Allergy to tirofiban, radiocontrast agent or Nitinol materials;
5. Any active bleeding within 30 days before stroke or recent bleeding (gastrointestinal, urinary, etc.);
6. parenchymal organ surgery or biopsy within 14 days before stroke;
7. History of heparin-induced thrombocytopenia;
8. Platelet count \< 100\*10\^9/L;
9. Being on hemodialysis or peritoneal dialysis; Known severe renal insufficiency (glomerular filtration rate \&lt; 30ml/min or serum creatinine \&gt; 220μmol/L).
10. Subjects requiring hemodialysis or peritoneal dialysis or who have contraindications to angiography for any reason;
11. The expected survival time is less than half a year (such as malignant tumors, serious heart and lung diseases, etc.);
12. Have participated in other interventional clinical studies that may have an impact on the outcome assessment;
13. Other circumstances that the investigator considers inappropriate for participation in the study or that may pose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to mental illness, cognitive or emotional disorder).
14. The midline shift of the brain or cerebral hernia, ventricular mass effect;
15. Acute intracranial hemorrhage on CT or MRI;
16. New bilateral acute stroke or intracranial multi-drainage large vessel occlusion;
17. Simple extracranial occlusion of the internal carotid artery.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Principal investigator: Xiang Luo — Tongji Hospital
• Study coordinator: Xiang Luo

Conditions: Acute Ischemic Stroke, Vessel Occlusion, mechanical thrombectomy, acute ischemic stroke, successful recanalization, tirofiban