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The efficacy and safety of early Tirofiban adjunctive to endovascular treatment in acute basilar artery occlusive stroke (BASILAR-2)

The efficacy and safety of early Tirofiban adjunctive to endovascular treatment in acute basilar artery occlusive stroke (BASILAR-2)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101044
Enrollment
Unknown
Registered
2025-04-18
Start date
2025-04-18
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Acute ischemic stroke

Interventions

Endovascular treatment + tirofiban group:Treated with tirofiban. Dosage of tirofiban: Arterial administration of tirofiban, intravenous continuation until 24 hours of onset. Antithrombotic drugs were
Endovascular treatment + placebo group:Placebo treatment with tirofiban, the usage is the same as that of tirofiban. Antithrombotic drugs were administered according to guidelines after the 24th hour

Sponsors

The Second Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>=18 years old; 2. Preliminary judgment of acute ischemic stroke based on clinical symptoms or imaging examination; 3. Acute ischemic stroke confirmed by cranial imaging and basilar artery occlusion (including isolated vertebral artery V4 segment and distal occlusion); 4. NIHSS score >=6 points; 5. PC-ASPECTS score >=5 points; 6.mTICI>=2b; 7. The time from onset to randomization is within 24 hours; 8. Signed written informed consent by the patient or family member.

Exclusion criteria

Exclusion criteria: 1. Intracranial hemorrhage confirmed by head CT or MRI; 2. The mRS score before the onset of the disease >= 2 points; 3. Antiplatelet aggregation therapy is planned during and after surgery; 4. Pregnant or lactating women; 5. Genetic or acquired hemorrhagic constitution, anticoagulant factor deficiency; or have used anticoagulants with an INR > 1.7; 6. Blood glucose 22.2mmol/L, platelet < 90*10^9/L; 7. Life expectancy of < 6 months due to any advanced disease; 8. Expected inability to complete follow-up; 9. Intracranial aneurysm, arteriovenous malformation; 10. Intracranial mass lesions; 11. Patients with severe hepatic and renal insufficiency; 12. Participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Improvement of mRS scores;Incidence of symptomatic intracranial hemorrhage (Sich) within 48h and 90 day mortality;

Secondary

MeasureTime frame
mRS scores 0-2 (%);mRS scores 0-3 (%);NIHSS score 5-7 days after medication, if the time of discharge is earlier than 5-7 days, the time of discharge shall prevail;90-day EQ-5D scale score;Incidence of asymptomatic intracranial hemorrhage (aSICH) within 48h;Complication rate of non intracranial hemorrhage (including gastrointestinal bleeding, urethral bleeding, oral or nasal mucosal bleeding, subcutaneous hematoma, etc.);Incidence of non hemorrhagic serious adverse events (including cerebral hernia, pneumonia, respiratory failure, circulatory failure, stress ulcer, secondary epilepsy, urinary tract infection, sepsis, renal failure, acute coronary syndrome, venous thrombosis and psychiatric symptoms);Thrombocytopenia (defined as platelet count <90*10^9 /l in blood routine examination within 48h after medication);

Countries

China

Contacts

Public ContactWenjie Zi

Department of Neurology, Xinqiao Hospital The Second Affiliated Hospital of the Army Medical University

ziwenjie@126.com+86 185 2303 3816

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026