NCT03197194

A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the THEIA study is to determine if Alteplase administrated within 4.5 hours improve visual deficit due to acute CRAO with a good safety profile.

Conditions

• Central Retinal Artery Occlusion

Interventions

Type	Name	Description
DRUG	Alteplase	alteplase administered as an intravenous infusion (0.9 mg/kg; maximum dose 90 mg): 10% given as an IV bolus, followed immediately by the remaining given as an IV infusion over 1 hour.
DRUG	acetylsalicylic acid	one tablet of aspirin 300 mg
DRUG	Placebo Oral Tablet	One placebo oral tablet which doesn't contain the active ingredient acetyl salicylic acid
DRUG	placebo IV	IV saline solution (0.9 %):10 mL in a syringe administered over 1 minute, followed by 50 mL as an infusion over 1 hour

Timeline

• Start date: 2018-06-08
• Primary completion: 2024-01-16
• Completion: 2024-01-16
• First posted: 2017-06-23
• Last updated: 2024-01-24

Locations

17 sites across 1 country: France