Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke

Phase

N/A

Condition

Stroke

Cardiac Ischemia

Occlusions

Treatment

Tirofiban

Placebo

Clinical Study ID

NCT07026318

ANGEL-DRUG

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Posteriorcirculation: pc-ASPECTS ≥6
Occlusion of intracranial internal carotid artery (ICA), M1 segment of middlecerebral 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

Exclusion Criteria:

Intracranial hemorrhage confirmed by imaging prior to randomization, or majorintracranial hemorrhage on intraprocedural flat-panel CT
Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset, ormajor 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 GPIIb/IIIa inhibitor used post treatment

Study Design