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NCT Number: NCT07026318

Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 101118, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Proportion of patients with mRS 0-2

    Time frame: 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 outcomes

  1. Change in NIHSS score from baseline

    Time frame: 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

  2. Vascular recanalization rate assessed by CT/MR angiography

    Time frame: 36±12 hours post-randomization

    Vascular recanalization rate assessed by CT/MR angiography

  3. Change in infarct volume

    Time frame: 7±3 days post-randomization or discharge

    Change in infarct volume

  4. Distribution of mRS scores

    Time frame: 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.

  5. Proportion of patients achieving mRS 0-1

    Time frame: 90±7 days

    Proportion of patients achieving mRS 0-1

  6. Proportion of patients achieving mRS 0-3

    Time frame: 90±7 days

    Proportion of patients achieving mRS 0-3

  7. Incidence of Pharmacologic rescue therapy

    Time frame: 90±7 days

    Incidence of Pharmacologic rescue therapy

  8. Incidence of rescue therapy

    Time frame: 90±7 days

    Incidence of rescue therapy

  9. EQ-5D-5L utility score

    Time frame: 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.

  10. Probability of symptomatic intracranial hemorrhage

    Time frame: 48 hours

    Probability of symptomatic intracranial hemorrhage (Heidelberg Standards)

  11. All-cause mortality

    Time frame: 90±7 days post-randomization

    All-cause mortality

  12. Probability of any intracranial hemorrhage

    Time frame: 48 hours post-randomization

    Probability of any intracranial hemorrhage (Heidelberg Standards)

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaochuan Huo, Doctor

CONTACT

[email protected]

+86 13716292262

Xin Tong, Doctor

CONTACT

[email protected]

+86 17810651085

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke: A Multicenter, Prospective, Double-blind, Vehicle-controlled, Randomized Controlled Trial

Acronym: ANGEL-DRUG

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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