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NCT07026318 | RECRUITING | Acute Ischemic Stroke

Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke
Sponsor:

Beijing an real hospital

Brief Summary:

This randomized controlled trial aims to evaluate whether adjunctive tirofiban therapy combined with endovascular treatment (EVT) improves neurological outcomes in patients with acute large vessel occlusion due to large-artery atherosclerosis. Patients will be randomized to receive either tirofiban or matching placebo after EVT. The primary efficacy endpoint is the proportion of patients achieving functional independence (modified Rankin Scale 0-2) at 90±7 days, while the safety endpoint is the probability of symptomatic intracranial hemorrhagewithin 48 hours after randomization.

Condition or disease

Acute Ischemic Stroke

Intervention/treatment

Tirofiban

Placebo

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 716 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke: A Multicenter, Prospective, Double-blind, Vehicle-controlled, Randomized Controlled Trial
Actual Study Start Date : 2025-08-15
Estimated Primary Completion Date : 2027-03-01
Estimated Study Completion Date : 2027-04-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Age ≥18 years
  • 2. Pre-stroke modified Rankin Scale (mRS) score of 0-1
  • 3. Acute ischemic stroke symptoms present within 24 hours of last known well time
  • 4. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6
  • 5. Anterior circulation: Alberta Stroke Program Early CT Score (ASPECTS) ≥6 Posterior circulation: pc-ASPECTS ≥6
  • 6. Occlusion of intracranial internal carotid artery (ICA), M1 segment of middle cerebral artery (MCA), V4 segment of vertebral artery, or basilar artery
  • 7. Clinical care team plans to perform endovascular thrombectomy (EVT)
  • 8. Subject or legally authorized representative can provide informed consent
  • 9. Residual stenosis ≥50% without planned angioplasty/stenting
Exclusion Criteria
  • 1. Intracranial hemorrhage confirmed by imaging prior to randomization, or major intracranial hemorrhage on intraprocedural flat-panel CT
  • 2. Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset, or major surgery within 14 days
  • 3. Bleeding diathesis including coagulopathy (platelets \<100×10⁹/L, aPTT \>50s, or INR \>2.0), DOAC use within 48 hours, or history of HIT
  • 4. Pregnancy or lactation at admission
  • 5. Contraindications to radiographic contrast agents, nickel, titanium or their alloys
  • 6. Life expectancy \<6 months
  • 7. Pre-existing neurological/psychiatric conditions that may confound assessment
  • 8. Severe renal insufficiency (GFR \<30mL/min or Scr \>220μmol/L \[2.5mg/dL\])
  • 9. Arterial tortuosity or anomalies preventing device delivery
  • 10. Unlikely to complete 90-day follow-up
  • 11. Any confirmed cardioembolic source (including atrial fibrillation, valvular disease, intracardiac thrombus, recent MI, cardiomyopathy with EF \<30%, etc.)
  • 12. Tirofiban or other GP IIb/IIIa inhibitor use before randomization or other GP IIb/IIIa inhibitor used post treatment
Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke

Location Details

NCT07026318

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Locations

RECRUITING

China, Beijing Municipality

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China, 101118