Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke

Not Applicable

Not yet recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Tirofiban; Drug: Placebo

• Registration Number: NCT07026318
• Lead Sponsor: Beijing Anzhen 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18
• Study Start: 2025-07-01
• Primary Completion: 2027-03-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 716

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tirofiban group	Tirofiban	Receive Tirofiban treatment following endovascular therapy
placebo group	Placebo	Receive placebo treatment after endovascular therapy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)
Vascular recanalization rate assessed by CT/MR angiography	36±12 hours post-randomization	Vascular recanalization rate assessed by CT/MR angiography
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
Change in infarct volume	7±3 days post-randomization or discharge	Change in infarct volume
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.

Trial Locations

Locations (1)

Beijing Anzhen Hospital Affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China