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The Efficacy and Safety of Tirofiban after Intravenous Thrombolysis for Acute Branch Atherosclerosis disease:a prospective, open-label, blinded-end point, randomized controlled trial

The Efficacy and Safety of Tirofiban after Intravenous Thrombolysis for Acute Branch Atherosclerosis disease:a prospective, open-label, blinded-end point, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118396
Enrollment
Unknown
Registered
2026-02-04
Start date
2026-02-05
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute branch Atherosclerosis disease

Interventions

control group:Dual Antiplatelet Therapy (DAPT)(Aspirin + Clopidogrel)
tirofiban group:tirofiban

Sponsors

Chengdu Second People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–80 years; 2. Acute ischemic stroke confirmed by head CT, MRI, or DWI; 3. Meets indications for intravenous thrombolysis, has no contraindications, and has received thrombolytic therapy; 4. NIHSS score =5 at 1 hour after completion of intravenous thrombolysis; 5. DWI sequence (slice thickness 5 mm) suggests a penetrating artery lesion and meets at least one of the following: ? Posterior limb of the internal capsule infarction (LSA territory): lesion diameter >15 mm, involving =3 slices, and stenosis of the responsible vessel 50%) or occlusion of the main branch artery³; ? Posterior-type lenticulostriate artery infarction: ? Multiple infarcts in a penetrating artery distribution; 6. The subject provides informed consent, voluntarily participates, and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. High-risk factors for cardioembolism: atrial fibrillation, atrial flutter, acute myocardial infarction, severe valvular heart disease, dilated cardiomyopathy, infective endocarditis; 2. Cortical or watershed infarction, or imaging suggesting high risk of hemorrhage: such as severe white matter disease Blennow score 3 or modified Fazekas score 3, multiple lacunar infarcts, or lacunar state; 3. Patients who should or have received arterial thrombolysis or mechanical thrombectomy; 4. Stroke with other clear etiology: such as moyamoya disease, arterial dissection, vasculitis, etc. 5. Pre-onset modified Rankin Scale mRS score = 1; 6. Stenosis = 50% in the ipsilateral extracranial or intracranial large arteries; 7. Bleeding tendency or coagulation abnormalities: platelet count 15s, APTT >40s, international normalized ratio INR >1.5, use of new oral anticoagulants, hematological diseases, etc. 8. Abnormal liver function: alanine aminotransferase ALT or aspartate aminotransferase AST > 3 times the upper limit of normal; 9. Renal insufficiency: creatinine clearance rate 10 mm or arteriovenous malformations; 14 Active or recent clinical bleeding events e.g., gastrointestinal bleeding; 15 Malignant hypertension; 16 Life expectancy = 6 months; 17 Contraindications to MRI; 18 Women during menstruation, pregnant, or breastfeeding; 19 Patients currently participating in other clinical studies; 20 Allergy to tirofiban; 21 Planned intracranial, intraspinal, or other major surgery within the next three months; 22 Long-term use or current use of dual antiplatelet therapy within 2 weeks prior to randomization; 23 Other conditions unsuitable for the study, such as psychiatric disorders, cognitive or emotional impairments, and inability to comply with study procedures.

Design outcomes

Primary

MeasureTime frame
Primary Safety Outcome(s);mRS 0-1 at 90 days (%);

Secondary

MeasureTime frame
Incidence of END within 7 days after randomization;Proportion of Patients with 90?Day mRS Score 0–2 (%);Secondary Safety Endpoint(s);Change in NIHSS score within 7 days;Rate of early neurological improvement within 7 days;Occurrence of new vascular events within 90 days;

Countries

China

Contacts

Public ContactWang Jian

Chengdu Second People’s Hospital

42523748@qq.com+86 28 6510 8275

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026