Clinical trial

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

NCT03197194

Name

RC17_0061

Description

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.

Trial arms

Trial start

2018-06-08

Estimated PCD

2024-01-16

Trial end

2024-01-16

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

A : Alteplase

Other names:

Actilyse

acetylsalicylic acid

one tablet of aspirin 300 mg

Arms:

B : Acetylsalicylic Acid

Other names:

Aspirin

Placebo Oral Tablet

One placebo oral tablet which doesn't contain the active ingredient acetyl salicylic acid

Arms:

A : Alteplase

Other names:

Placebo aspirin

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

Arms:

B : Acetylsalicylic Acid

Other names:

Placebo Actilyse

Size

Primary endpoint

visual acuity (VA) improvement after treatment

1 month

Eligibility criteria

Inclusion Criteria: * Patients aged up to 18 years * CRAO diagnosis by fundoscopic examination or non-mydriatic retinophotography (NMR) performed by an ophthalmologist. * Blindness defined according to WHO classification as visual acuity \<1/20 (20/400). * Treatment intervention should be initiated by a stroke team as quickly as possible and within 4.5 hours from symptom onset. * No clinical (e.g headache with jaw claudication or scalp tenderness, no temporal pulse) or laboratory evidence (elevated CRP) of giant cell arteritis * No clinical or radiological evidence of stroke within the last 3 months. * Patients covered by health care insurance (social security) * Written informed consent obtained. Exclusion Criteria: * Symptoms onset more than 4.5 h prior to infusion start or undetermined time of symptom onset. * Minor VA deficit or VA rapidly improving before start of infusion. * CRAO without foveal ischemia. * Other retinal vascular disease: occlusion of branch of the CRA without significant VA loss, occlusion of the retinal vein, proliferative diabetic retinopathy or any other severe retinopathy. * Clinical or laboratory evidence of temporal arteritis. * Evidence of ICH or ischemic stroke on the pre-administration CT scan or MRI. * Pregnant or lactating women * Minors * Adults under guardianship or trusteeship * Any contraindication to alteplase * Any contraindication to aspirin

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}

Updated at

2024-01-24

1 organization

Organization

Nantes University Hospital