Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tirofiban, Placebo.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke: A Multicenter, Prospective, Double-blind, Vehicle-controlled, Randomized Controlled Trial
Overview
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
- Drug Tirofiban
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. - Drug Placebo
Following endovascular treatment, patients receive normal saline placebo, with the dosage calculated in the same manner as that of tirofiban in the experimental group.
Primary outcome measures
- Proportion of patients with mRS 0-2 [Time frame: 90±7 days]
Secondary outcome measures (12)
- Change in NIHSS score from baseline [Time frame: 36±12 hours post-randomization]
- Vascular recanalization rate assessed by CT/MR angiography [Time frame: 36±12 hours post-randomization]
- Change in infarct volume [Time frame: 7±3 days post-randomization or discharge]
- Distribution of mRS scores [Time frame: 7±3 days/discharge；90±7 days post-randomization]
- Proportion of patients achieving mRS 0-1 [Time frame: 90±7 days]
- Proportion of patients achieving mRS 0-3 [Time frame: 90±7 days]
- Incidence of Pharmacologic rescue therapy [Time frame: 90±7 days]
- Incidence of rescue therapy [Time frame: 90±7 days]
- EQ-5D-5L utility score [Time frame: 90±7 days]
- Probability of symptomatic intracranial hemorrhage [Time frame: 48 hours]
- All-cause mortality [Time frame: 90±7 days post-randomization]
- Probability of any intracranial hemorrhage [Time frame: 48 hours post-randomization]
Eligibility criteria
Inclusion criteria
- Age ≥18 years
- Pre-stroke modified Rankin Scale (mRS) score of 0-1
- Acute ischemic stroke symptoms present within 24 hours of last known well time
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6
- Anterior circulation: Alberta Stroke Program Early CT Score (ASPECTS) ≥6 Posterior circulation: pc-ASPECTS ≥6
- Occlusion of intracranial internal carotid artery (ICA), M1 segment of middle cerebral artery (MCA), V4 segment of vertebral artery, or basilar artery
- Clinical care team plans to perform endovascular thrombectomy (EVT)
- Subject or legally authorized representative can provide informed consent
- Residual stenosis ≥50% without planned angioplasty/stenting
Exclusion criteria
- Intracranial hemorrhage confirmed by imaging prior to randomization, or major intracranial hemorrhage on intraprocedural flat-panel CT
- Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset, or major surgery within 14 days
- Bleeding diathesis including coagulopathy (platelets <100×10⁹/L, aPTT >50s, or INR >2.0), DOAC use within 48 hours, or history of HIT
- Pregnancy or lactation at admission
- Contraindications to radiographic contrast agents, nickel, titanium or their alloys
- Life expectancy <6 months
- Pre-existing neurological/psychiatric conditions that may confound assessment
- Severe renal insufficiency (GFR <30mL/min or Scr >220μmol/L \[2.5mg/dL\])
- Arterial tortuosity or anomalies preventing device delivery
- Unlikely to complete 90-day follow-up
- Any confirmed cardioembolic source (including atrial fibrillation, valvular disease, intracardiac thrombus, recent MI, cardiomyopathy with EF <30%, etc.)
- Tirofiban or other GP IIb/IIIa inhibitor use before randomization or other GP IIb/IIIa inhibitor used post treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Anzhen Hospital Affiliated to Capital Medical University — Beijing
Identifiers
NCT: NCT07026318 · ANGEL-DRUG