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NCT06265051CompletedPhase 2/3

Tirofiban After Successful MT Recanalization in AIS

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

Source: ClinicalTrials.gov · Last updated 11 Mar 2026

Brief summary (registry, in English)

Acute ischemic stroke with large vessel occlusion is a frequently occurring life-threatening condition. Although endovascular treatment can effectively open occluded vessels, the successful reperfusion rate exceeds 80%, but the rate of good prognosis is less than 50%. The current clinical focus is on how to improve futile recanalization. Tirofiban is widely used in the treatment of stroke, as it can effectively prevent vascular reocclusion and improve microcirculation perfusion. It has the potential to improve futile recanalization, but there is a lack of high-level evidence-based medical support. This multicenter, prospective, double-blind, randomized controlled trial was conducted to assess the effectiveness and safety of sequential tirofiban therapy following successful mechanical thrombectomy within 24 hours of onset.

Status (registry)
Completed
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
1380 (actual)
First submitted
9 Feb 2024
Start date
9 Apr 2024
Primary completion date
29 Dec 2025
Lead sponsor
Xiang Luo
Diseases
Stroke
NCT number
NCT06265051

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 1380
  • From 9 Apr 2024 to the primary completion date, 29 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any active bleeding within 30 days before stroke or recent bleeding (gastrointestinal, urinary, etc.);
  • parenchymal organ surgery or biopsy within 14 days before stroke;

Other illness

  • Allergy to tirofiban, radiocontrast agent or Nitinol materials;
  • History of heparin-induced thrombocytopenia;
  • The expected survival time is less than half a year (such as malignant tumors, serious heart and lung diseases, etc.);
  • 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).
  • Acute intracranial hemorrhage on CT or MRI;
  • New bilateral acute stroke or intracranial multi-drainage large vessel occlusion;

Lab values

  • Platelet count \< 100\*10\^9/L;
  • Being on hemodialysis or peritoneal dialysis; Known severe renal insufficiency (glomerular filtration rate \&lt; 30ml/min or serum creatinine \&gt; 220μmol/L).

Other

  • Intra-arterial thrombolysis;
  • Tirofiban was used within 24 hours before endovascular treatment
  • Women who are known to be pregnant or lactating, or have a positive pregnancy test before randomization;
  • Subjects requiring hemodialysis or peritoneal dialysis or who have contraindications to angiography for any reason;
  • Have participated in other interventional clinical studies that may have an impact on the outcome assessment;
  • The midline shift of the brain or cerebral hernia, ventricular mass effect;
  • Simple extracranial occlusion of the internal carotid artery.

Who the study is looking for

  • Age ≥18 years old;
  • NIHSS score: 6-30;
  • 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.
  • mRS 0-1 before the stroke;
  • Subject or legal representative can sign an informed consent form;
  • 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;
  • ASPECTS≥6 on NCCT or DWI;
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.