Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke

NCT ID: NCT07026318

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

716 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-15

Study Completion Date

2027-04-01

Brief Summary

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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

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tirofiban group

Receive Tirofiban treatment following endovascular therapy

Group Type EXPERIMENTAL

Tirofiban

Intervention Type DRUG

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.

placebo group

Receive placebo treatment after endovascular therapy.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Following endovascular treatment, patients receive normal saline placebo, with the dosage calculated in the same manner as that of tirofiban in the experimental group.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaochuan Huo, Doctor

Role: CONTACT

+86 13716292262

Xin Tong, Doctor

Role: CONTACT

+86 17810651085

Other Identifiers

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ANGEL-DRUG

Identifier Type: -

Identifier Source: org_study_id

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