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NCT Number: NCT07379190

HR-MRI-Directed Tirofiban Therapy for Late-Window Acute Ischemic Stroke (TIAN)

This study aims to address the existing clinical challenges by introducing high-resolution magnetic resonance vessel wall imaging (HR-MRI), an advanced imaging technology, to achieve precise etiological classification in patients with acute ischemic stroke (AIS) beyond the time window. HR-MRI allows clear visualization of intracranial arterial wall structures and direct identification of key pathological features of the culprit vessel, including atherosclerotic plaques, vascular wall remodeling, and intracranial hemorrhage, thereby enabling reliable differentiation between intracranial atherosclerotic large artery atherosclerosis (ICAS-LAA) stroke and other etiological subtypes such as cardiogenic embolism. Based on the latest clinical demands and advances in imaging technology, this study intends to evaluate the efficacy and safety of tirofiban in patients with ICAS-LAA stroke beyond the time window under the precise guidance of HR-MRI. It is expected to provide high-level evidence-based medical evidence for this specific patient population and further optimize clinical diagnosis and treatment strategies.

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Key information

Conditions

Stroke, Acute Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Infarction Cerebrovascular Disorders Infarction Ischemia Ischemic Stroke Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Stroke, Ischemic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Weifang People's Hospital

Weifang, China/Shandong Province, 261000, China

Location status: Recruiting

Location contact

Weili Li, MD

CONTACT

[email protected]

86-0536-8192680

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years old;
  • Acute ischemic stroke (AIS) in the anterior intracranial circulation (internal carotid artery system) confirmed by clinical symptoms and imaging examinations;
  • Time from symptom onset or last known normal state to randomization: > 24 hours and ≤ 7 days;
  • Stroke subtype confirmed as intracranial large artery atherosclerosis (ICAS) by high-resolution vessel wall imaging (HR-VWI) according to the TOAST classification, with cardiogenic embolism and other etiologies excluded;
  • Baseline National Institutes of Health Stroke Scale (NIHSS) score of 4-20 at the time of randomization;
  • Signed informed consent form obtained from the patient or their legal representative.

Exclusion criteria

  • Planned to receive reperfusion therapy (endovascular therapy or intravenous thrombolysis)；
  • Intracranial hemorrhage confirmed by computed tomography (CT)；
  • Definite or suspected cardiogenic embolism；
  • History of atrial fibrillation or current electrocardiogram indicating atrial fibrillation；
  • Acute ischemic stroke caused by other etiologies, such as Moyamoya disease, arterial dissection, arteritis, etc；
  • Imaging examinations indicating that the area of the current cerebral infarction exceeds 1/2 of the area of a single cerebral lobe;
  • Known contraindications to antiplatelet therapy, including hematochezia, gastrointestinal bleeding, or any other hemorrhagic disorders;
  • History of hypersensitivity to aspirin;
  • Definite indication for anticoagulant therapy expected during the study period (e.g., atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state, etc.);
  • Complicated with malignant tumors, chronic hemodialysis, severe renal insufficiency (glomerular filtration rate [GFR] < 30 ml/min or serum creatinine [Cr] > 220 μmol/L (2.5 mg/dl)), or severe hepatic insufficiency (serum alanine aminotransferase [ALT] > 2 times the upper limit of normal [ULN], or serum aspartate aminotransferase [AST] > 2 times the ULN);
  • Severe heart failure (New York Heart Association [NYHA] Functional Classification Class III or IV);
  • Complicated with severe non-cardiovascular comorbidities, with an estimated survival time < 6 months;
  • Concurrent new cerebral infarction in both anterior and posterior circulations;
  • Inability to complete the follow-up procedures;
  • Presence of other known neurological disorders that may complicate the follow-up;
  • Concurrent participation in other therapeutic clinical trials with incomplete treatment and follow-up;
  • Other conditions that the investigators consider inappropriate for enrollment in this study.

Treatment and study plan

tirofiban

Drug

Intravenous tirofiban was administered within 30 minutes of randomization, with an initial bolus infusion at a rate of 0.4 μg/(kg·min) for 30 minutes, followed by a continuous infusion at 0.1 μg/(kg·min) for 47.5 hours.

Dual antiplatelet therapy

Drug

Initiate dual antiplatelet therapy as early as possible (aspirin 100 mg/day plus clopidogrel 75 mg/day) for a total of 21 days, followed by long-term maintenance with aspirin 100 mg/day alone. For patients at high risk of stroke, such as those with severe stenosis of major blood vessels, dual antiplatelet therapy should be administered for 90 days.

Other names: aspirin, clopidogrel

Primary outcomes

  1. Proportion of participants with functional independence outcome [modified Rankin Scale(mRS) score 0-1]

    Time frame: 90 ± 7 days after randomization

    the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death); a lower score indicates a better prognosis.

Secondary outcomes

  1. Proportion of participants with good prognosis (mRS score 0-2)

    Time frame: 90 ± 7 days after randomization

    the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death);a lower score indicates a better prognosis.

  2. Proportion of participants with mRS score 0-3

    Time frame: 90 ± 7 days after randomization

    the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death);a lower score indicates a better prognosis.

  3. Distribution of mRS scores

    Time frame: 90 ± 7 days after randomization

    the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death);a lower score indicates a better prognosis.

  4. EuroQol Five-Dimension Questionnaire (EQ-5D) score

    Time frame: 90 ± 7 days after randomization

    The EQ-5D is a standardized patient-reported outcome measure for evaluating health-related quality of life (HRQoL), consisting of the EQ-5D descriptive system (assessing mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and the EQ visual analog scale (EQ-VAS). The utility score derived from the descriptive system will be adopted for statistical analysis, with a range of -0.594 to 1.0 based on the applicable value set. A higher score indicates better health-related quality of life: a score of 1.0 represents perfect health, 0 equates to a health state equivalent to death, and negative scores reflect health states worse than death. The EQ-VAS (0-100 scale, 0 = worst imaginable health state; 100 = best imaginable health state) will be analyzed as a supplementary index.

  5. Barthel Index (BI) score

    Time frame: 90 ± 7 days after randomization

    the BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);

  6. Proportion of participants with neurological improvement within 24 hours of randomization [≥2-point reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline]

    Time frame: 24 ± 6 hours

    the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits);

  7. National Institutes of Health Stroke Scale (NIHSS) scores

    Time frame: Time Frame: 24h; before discharge; day7

    NIHSS score increased by more than 4 points);the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits)

  8. Proportion of participants with symptomatic intracranial hemorrhage (sICH) within 24 hours of randomization

    Time frame: 24 ± 6 hours

    clinical safety endpoint

  9. Early neurological deterioration(END)

    Time frame: 24 ± 6 hours

    defined as NIHSS score increased by #4 points within 24 hours

  10. Incidence of serious adverse events (SAEs)

    Time frame: 24 ± 6 hours;

    clinical safety endpoint

  11. Incidence of any adverse events

    Time frame: 24 ± 6 hours;

    clinical safety endpoint

  12. Recurrent stroke

    Time frame: 90 ± 7 days after randomization

    clinical safety endpoint;the new neurological deficit must be accompanied by corresponding new ischemic or hemorrhagic lesions on brain CT or MRI, which are not contiguous with the index stroke lesion and do not correspond to the vascular territory of the index stroke.

  13. all-cause mortality;

    Time frame: 90 ± 7 days after randomization

    clinical safety endpoint; to observe the proportion of all patients who died in each group

  14. stroke-related mortality

    Time frame: 90 ± 7 days after randomization

    clinical safety endpoint;The proportion of stroke related deaths in each group

  15. Proportion of participants with any intracranial hemorrhage

    Time frame: 24 ± 6 hours

    imaging safety endpoints; to observe the proportion of intracranial hemorrhage patients in each group

Study contacts

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

Weili Li, MD

CONTACT

[email protected]

86-0536-8192680

Sponsors and collaborators

Lead sponsor

Weifang Medical University

Other

Collaborators

  • Linyi People's Hospital
  • Qianfoshan Hospital

Registry information

Official study title

Efficacy and Safety of Tirofiban Therapy in Acute Ischemic Stroke Patients Beyond the Time Window Guided by High-Resolution Magnetic Resonance Imaging

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 30, 2026
Registry last updated
Jun 25, 2026

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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