TENecteplase in Central Retinal Artery Occlusion Stuy (TenCRAOS) (NCT04526951) | Clinical Trial Compass
CompletedPhase 3
TENecteplase in Central Retinal Artery Occlusion Stuy (TenCRAOS)
Belgium, Denmark81 participantsStarted 2020-10-30
Plain-language summary
TENecteplase in Central Retinal Artery Occlusion (TenCRAOS): A Prospective, randomized-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomization).
A Prospective, randomized-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomization). At all participating centers, ophthalmologists are involved in the diagnosis and visual outcome measurements using a standardized protocol. The patients will be promptly examined by the ophthalmologist. As soon as the CRAO is diagnosed by the ophthalmologist, the patients will be managed in the stroke unit during treatment, monitoring, and medical investigations. After treatment in the stroke unit, the patients will be re-examined by an ophthalmologist and a neurologist as an out-patient at (30 ±5) and 90 (±15) days
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Non-arteritic central retinal artery occlusion with ≥ 1.0 logMAR visual acuitiy and symptoms lasting less than 4.5 hours.
✓. Ability to administer the Investigator Medicinal Product (IMP) within 4.5 hours of symptom onset.
✓. Age ≥18 years.
✓. Informed written consent of the patient.
✓. A woman of childbearing potential (WOCBP) must confirm that in her opinion, she cannot be pregnant, OR if there is a possibility that she is pregnant, a negative pregnancy test must be confirmed before any IMP is given.
Exclusion criteria
✕. Other active intervention targeting CRAO.
✕. Branch retinal artery occlusion, cilioretinal artery supplying the macula, combined arterial-venous occlusion, proliferative diabetic retinopathy, elevated intraocular pressure (\> 30 mmHg) or clinical suspicion of ophthalmic artery occlusion occlusion (e.g. choroidal nonperfusion, absence of cherry red spot, no light perception).
✕. Systemic diseases; severe general diseases, systemic arterial hypertension (blood pressure \>185/110 mmHg), despite medical therapy, or clinical suspicion of acute systemic inflammation.
What they're measuring
1
Proportion of patients with ≤ 0.7 logMAR visual acuity in the affected eye at 30 (±5) days after treatment, representing an improvement in visual acuity of at least 0.3 logMAR (intention-to-treat (ITT) analysis).
✕. Presence of intracranial haemorrhage on brain MRI/CT.
✕. Medical history: heart attack within the last 6 weeks, intracerebral bleeding or neurosurgical operation within the last 4 weeks, therapy with anticoagulation, allergic reaction to contrast agent, hemorrhagic diathesis, aneurysms, inflammatory vascular diseases (eg, giant cell arteritis, granulomatosis with polyangitis), endocarditis, or gastric ulcer.
✕. No willingness and ability of the patient to participate in all follow-up examinations.
✕. Pregnancy (if suspicion of pregnancy s-hCG or u-hCG must be negative).
✕. Allergy or intolerance to any ingredients of IMP or placebo or gentamicin.