Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke

NCT07026318 | Recruiting DMC

• 1 other identifier: ANGEL-DRUG
• Study Type: interventional
• Target: 716
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; Tirofiban; placebo; Randomized Controlled Trial; Intracranial Atherosclerotic

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with mRS 0-2

  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.

  90±7 days

Secondary Outcomes (12)

• Change in NIHSS score from baseline

  36±12 hours post-randomization

• Vascular recanalization rate assessed by CT/MR angiography

  36±12 hours post-randomization

• Change in infarct volume

  7±3 days post-randomization or discharge

• Distribution of mRS scores

  7±3 days/discharge；90±7 days post-randomization

• Proportion of patients achieving mRS 0-1

  90±7 days

Study Arms (2)

Tirofiban group

EXPERIMENTAL

Receive Tirofiban treatment following endovascular therapy

Drug: Tirofiban

placebo group

PLACEBO COMPARATOR

Receive placebo treatment after endovascular therapy.

Drug: Placebo

Interventions

Tirofiban 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.

Tirofiban group

Placebo 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.

placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 101118, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tirofiban

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Xiaochuan Huo, Doctor

CONTACT

+86 13716292262; hxc810909@163.com

Xin Tong, Doctor

CONTACT

+86 17810651085; tomice123@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 18, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)