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Tirofiban for the Prevention of New Ischemic Brain Lesions After Intracranial Angioplasty and Stenting: A Randomized Controlled Study

Tirofiban for the Prevention of New Ischemic Brain Lesions After Intracranial Angioplasty and Stenting: A Randomized Controlled Study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119130
Enrollment
Unknown
Registered
2026-02-24
Start date
2026-02-24
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Symptomatic intracranial arterial stenosis

Interventions

Tirofiban group:Postoperatively, Tirofiban will be administered immediately at 0.2 µg/kg/min for 30 minutes, followed by a maintenance infusion of 0.05 µg/kg/min for 11.5 hours, in addition to standar
Conventional treatment group:Standard postoperative medical therapy will be administered.

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 30 years <= age <= 80 years; 2. intracranial symptomatic atherosclerosis (ischaemic event including TIA or ischaemic stroke within the last 12 months. and that ischaemic event was associated with intracranial atherosclerosis (70-99% stenosis) including internal carotid artery - segment C7, middle cerebral artery - segment M1, basilar artery, vertebral artery segments V3 and V4)); 3. angioplasty (including stenting and/or balloon dilatation) 3 weeks after the ischaemic event; 4. immediate postoperative CT to exclude intracranial haemorrhage, subarachnoid haemorrhage, and subdural/extradural haemorrhage; 5. signing an informed consent form;

Exclusion criteria

Exclusion criteria: 1. Possess any contraindication to intracranial angioplasty 2. CT/MRI suggesting previous large cerebral infarction 3. Bleeding from the urinary tract or gastrointestinal tract within the last 30 days. 4. Major surgery within the last 14 days 5. Known history of coagulation disorders, platelet abnormalities or thrombocytopenia 6. Allergy to tirofiban 7. Platelet count = 220umol/L) 9. Life expectancy <1 year with serious diseases 10. Postoperative entrapment of diseased vessels or other imaging manifestations of high thrombotic risk. 11. Patient participation in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Incidence of symptomatic ischemic stroke within 72 hours after enrollment;Incidence of symptomatic intracranial hemorrhage (sICH) within 72 hours after enrollment;Incidence of new hyperintense lesions on diffusion-weighted MRI (DWI) within 72 hours after enrollment;

Secondary

MeasureTime frame
New-onset hemorrhagic stroke events within 30 days after enrollment;Systemic bleeding events within 72 hours after enrollment (e.g., gastrointestinal bleeding, access-site bleeding);New-onset ischemic stroke events within 30 days after enrollment;

Countries

China

Contacts

Public ContactYuxiang Gu

Huashan Hospital, Fudan University

captainbinye@126.com+86 52889999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026