Early tirofiban administration after intra-arterial thrombolysis in central retinal artery occlusion: Study protocol of a prospective, multicenter, placebo-controlled

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400090049

Enrollment

Unknown

Registered

2024-09-23

Start date

2024-10-01

Completion date

Unknown

Last updated

2024-09-30

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

Conditions

Center retinal artery occlusion

Interventions

Tirofiban group:None

non-Tirofiban group:None

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age ?18 years; (2) Clinical diagnosis of non-arteritic CRAO occurring 4.5-24 hours after symptom onset; (3) IAT with urokinase 500,000 units, administered manually via a microcatheter at a rate of 10,000 units per minute; (4) Best corrected visual acuity (BCVA) =20/63 (Snellen chart); (5) Absence of intracranial hemorrhage confirmed by head computed tomography (CT) after IAT; (6) Administration of tirofiban or placebo can commence within 0.5 hours after IAT.

Exclusion criteria

Exclusion criteria: 1. Ocular factors or diseases (1) Spontaneous improvement of vision or retinal perfusion at initial presentation (<4 hours after symptom onset); (2) Branch retinal artery occlusion; (3) Combined central retinal vein occlusion; (4) Suspicious ocular ischemic syndrome, such as ophthalmic artery occlusion or carotid artery occlusion; (5) Central retinal artery occlusion from iatrogenic cause; (6) Combined ocular pathologies interfering with visual outcome (e.g., diabetic macular edema, severe non-proliferative or proliferative diabetic retinopathy, severe cataract, glaucoma); (7) History of thrombolysis for CRAO or central retinal vein occlusion (CRVO). 2. Other factors or diseases (1) Severe renal, liver insufficiency, recent surgery, gastrointestinal hemorrhage, or coagulopathy; (2) Use of antiplatelet, anticoagulant, or fibrinolytic agents within 24 hours prior to recruitment; (3) Received IVT; (4) History of allergic reaction to tirofiban; (5) Unclear fundus information (e.g., vitreous hemorrhage) or suspected diagnoses; (6) Unwillingness to comply with follow-up or anticipated poor treatment adherence.

Design outcomes

Primary

Measure	Time frame
Functional visual recovery, improvement in visual acuity from 20/200 or worse at presentation to 20/100 or better improvement in visual acuity from 20/200 or worse at presentation to 20/100 or better;	—

Secondary

Measure	Time frame
Visual Field Index(VFI);superficial macular retinal vessel density;Ischemic stroke;Various bleeding complications;Ocular comorbidities;	—

Countries

China

Contacts

Public ContactSongdi Wu

Xi’an No.1 Hospital

liutong_1989@126.com+86 186 2926 5635

Outcome results

None listed

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