Acute Ischemic Stroke
Conditions
Keywords
Acute Ischemic Stroke, Tirofiban, placebo, Randomized Controlled Trial, Intracranial Atherosclerotic
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.
Interventions
DRUGTirofiban
After endovascular treatment, tirofiban is infused at a rate of 0.4 μg/kg/min for 30 minutes, followed by a maintenance infusion at 0.1 μg/kg/min until 24 hours postoperatively.
DRUGPlacebo
Following endovascular treatment, patients receive normal saline placebo, with the dosage calculated in the same manner as that of tirofiban in the experimental group.
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with mRS 0-2 | 90±7 days | Proportion of patients with Modified Rankin Scale (mRS) 0-2, Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of mRS scores | 7±3 days/discharge；90±7 days post-randomization | Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient. |
| Proportion of patients achieving mRS 0-1 | 90±7 days | Proportion of patients achieving mRS 0-1 |
| Proportion of patients achieving mRS 0-3 | 90±7 days | Proportion of patients achieving mRS 0-3 |
| Incidence of Pharmacologic rescue therapy | 90±7 days | Incidence of Pharmacologic rescue therapy |
| Incidence of rescue therapy | 90±7 days | Incidence of rescue therapy |
| Change in infarct volume | 7±3 days post-randomization or discharge | Change in infarct volume |
| Vascular recanalization rate assessed by CT/MR angiography | 36±12 hours post-randomization | Vascular recanalization rate assessed by CT/MR angiography |
| EQ-5D-5L utility score | 90±7 days | The EuroQol 5-Dimension 5-Level Utility Score (EQ-5D-5L utility score) ranges from -0.594 to 1.000 (Chinese value set), assessing health-related quality of life, with higher scores indicating better health status. |
| Probability of symptomatic intracranial hemorrhage | 48 hours | Probability of symptomatic intracranial hemorrhage (Heidelberg Standards) |
| All-cause mortality | 90±7 days post-randomization | All-cause mortality |
| Probability of any intracranial hemorrhage | 48 hours post-randomization | Probability of any intracranial hemorrhage (Heidelberg Standards) |
| Change in NIHSS score from baseline | 36±12 hours post-randomization | Change in National Institute of Health stroke scale score from baseline.The NIH Stroke Scale (NIHSS) score ranges from 0 to 42 points, with lower scores indicating better neurological function |
Countries
China
Contacts
Primary ContactXiaochuan Huo, Doctor
Backup ContactXin Tong, Doctor
Outcome results
None listed