TENecteplase in Central Retinal Artery Occlusion Stuy (TenCRAOS)

TENecteplase in Central Retinal Artery Occlusion Study (TenCRAOS): A Randomized Placebo-controlled Trial of Early Systemic Tenecteplase Treatment in Patients With Central Retinal Artery Occlusion.

Sponsors

Lead Sponsor: Oslo University Hospital

Source Oslo University Hospital
Brief 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

Detailed Description

Central retinal artery occlusion (CRAO) is an ophthalmologic emergency that, without prompt revascularization, bears high risk of permanent blindness. The condition is typically the result of an artery-to-artery embolism from a carotid plaque or cardio embolism. A recent meta-analysis of observational data indicates that prompt revascularization with systemic thrombolysis might improve outcome. A randomized controlled trial of early systemic thrombolysis for CRAO is therefore warranted. The aim of this project is to assess the effect of systemic tissue plasminogen activator tenecteplase versus placebo administered within 4.5 hours of CRAO onset in patients admitted to the participating hospitals in Europe. The main endpoint is the proportion of patients with ≤ 0.7 logMAR visual acuity 30 (±5) days after treatment, representing an improvement in visual acuity of at least 0.3 logMAR, equal to at least 15 letters/three lines on a visual acuity chart. In addition, we will access differences in visual field parameters and patient reported outcome measures between the groups. This study is based on a broad collaboration and interaction between leading ophthalmologists and neurologists in European centres.

Overall Status Recruiting
Start Date 2020-10-30
Completion Date 2024-01-31
Primary Completion Date 2023-10-31
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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). 30 (±5) days
Secondary Outcome
Measure Time Frame
Proportion of patients with ≤ 0.5 logMAR visual acuity in the affected eye at 30 (±5) and 90 (±15) days. 30 (±5) and 90 (±15) days
Mean improvement in logMAR visual acuity in the affected eye from baseline to 30 (±5) and 90 (±15) days. 30 (±5) and 90 (±15) days
Proportion of patients with visual recovery (logMAR ≤ 0.7) and (logMAR ≤ 0.5) in the affected eye 30 (±5) and 90 (±15) days in patients who were treated with tenecteplase within 3 hours of onset 30 (±5) and 90 (±15) days
Number of test points seen (of 100) on monocular Esterman perimetry at 30 (±5) and 90 (±15) days 30 (±5) and 90 (±15) days
Acute ischemic lesions on follow-up on diffusion-weighted (DWI) MRI or on brain CT at baseline and 24hrs. 24 hours
National Institutes of Health Stroke Scale score (NIHSS) at 24hrs and discharge. 24 hours
Modified Rankin Scale score (mRS) at discharge, 30 (±5) and 90 days (±15) days. Discharge, 30 (±5) and 90 days (±15) days.
Mean score on National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) at 30 (±5) and 90 (±15) days 30 (±5) and 90 (±15) days
Mean score on EQ-5D at 30 (±5) and 90 (±15) days 30 (±5) and 90 (±15) days
Presence of ocular neovascularisation at 30 (±5) and 90 (±15) days 30 (±5) and 90 (±15) days
Enrollment 78
Condition
Intervention

Intervention Type: Drug

Intervention Name: Intravenous injection of Tenecteplase and one dose of placebo tablet

Description: Drug: Tenecteplase Tenecteplase administered as an intravenous injection (0.25 mg/kg body weigh; maximum 25 mg)

Arm Group Label: Tenecteplase

Other Name: Metalyse

Intervention Type: Drug

Intervention Name: One tablet of Acetylsalicylic Acid and one dose of IV placebo

Description: 300 mg Acetylsalisylic acid

Arm Group Label: acetylsalicylic acid

Other Name: Aspirin

Eligibility

Criteria:

Inclusion Criteria: 1. Non-arteritic central retinal artery occlusion with ≥ 1.0 logMAR visual acuitiy and symptoms lasting less than 4.5 hours. 2. Ability to administer the Investigator Medicinal Product (IMP) within 4.5 hours of symptom onset. 3. Age ≥18 years. 4. Informed written consent of the patient. 5. 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: 1. No other active intervention targeting CRAO. 2. 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). 3. Systemic diseases; severe general diseases, systemic arterial hypertension (blood pressure >185/110 mmHg), despite medical therapy, or clinical suspicion of acute systemic inflammation. 4. Presence of intracranial haemorrhage on brain MRI/CT. 5. 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. 6. No willingness and ability of the patient to participate in all follow-up examinations. 7. Pregnancy (if suspicion of pregnancy s-hCG or u-hCG must be negative). 8. Allergy or intolerance to any ingredients of IMP or placebo or gentamicin. 9. Other conditions / circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, no fixed abode). 10. Significant bleeding disorder either at present or within the past 6 months. 11. Effective oral anticoagulant treatment, eg, warfarin sodium (INR >1.3). 12. Effective anticoagulant treatment with heparin or low molecular weight heparin the last 48 hours. 13. Any history of central nervous system damage (ie, neoplasm, aneurysm, intracranial or spinal surgery). 14. Known hemorrhagic diathesis. 15. Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with acute myocardial infarction). 16. Recent non-compressible vessel puncture within 2 weeks. 17. Recent trauma to the head or cranium. 18. Prolonged cardiopulmonary resuscitation (>2 minutes) within the past 2 weeks. 19. Acute pericarditis and/or subacute bacterial endocarditis. 20. Acute pancreatitis. 21. Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis. 22. Active peptic ulceration. 23. Arterial aneurysm and known arterial/venous malformation. 24. Neoplasm with increased bleeding risk. 25. Any known history of hemorrhagic stroke or stroke of unknown origin. 26. Known history of ischemic stroke or transient ischemic attack in the preceding 3 months. 27. Dementia.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Anne Hege Aamodt

Phone: +47 23074976

Email: [email protected]

Location
Facility: Status: Contact:
University Hospital Antwerp | Antwerp, Belgium Not yet recruiting Peter Vanacker +32 3 830 52 02 [email protected]
Aalborg University Hospital | Aalborg, Denmark Not yet recruiting Søren Due, Prof +45 97 66 00 00 [email protected]
Aarhus University Hospital | Aarhus, Denmark Not yet recruiting Claus Ziegler, MD PhD AProf +45 70 11 31 31 [email protected] Toke Bek, Prof Principal Investigator
Rigshospitalet University Hospital | Copenhagen, Denmark Not yet recruiting Thomas C Truelsen, MD PhD +4521810068 [email protected]
Helsinki University Hospital | Helsinki, Finland Not yet recruiting Petra Iljäs, MD PhD +358 9 4711 [email protected]
Helsinki University Hospita | Helsinki, Finland Not yet recruiting Daniel Strbian, Prof +358 9 4711 [email protected]
Turku University Hospital | Turku, Finland Not yet recruiting Pauli Ylikotila +358 2 3130000 [email protected]
Mater Misericordiae University Hospital | Dublin, Ireland Not yet recruiting Sean Murphy, MD, PhD +353 1 803 200 [email protected]
Vilnius University Hospital | Vilnius, Lithuania Not yet recruiting Jurgita Valalkiene, A/Prof MD +370 52365221 [email protected]
Sørlandet Hospital Trust | Arendal, Norway Not yet recruiting Arnstein Tveiten, MD PhD +4790 61 06 00 [email protected]
Haukeland University Hospital | Bergen, Norway Not yet recruiting Andrej Khanevski, MD, PhD +4755975000 [email protected]
Nordland Hospital Trust | Bodø, Norway Not yet recruiting Maria Carlsson, MD +4792881130 [email protected]
Vestre Viken Hospital Trust Drammen | Drammen, Norway Recruiting Ingvild Nakstad, MD +4795815868 [email protected]
Østfold Hospital Trust Kalnes | Grålum, Norway Not yet recruiting Barbara Ratajczak-Tretel, MD +4741597406 [email protected]
Innlandet Hospital Trust | Lillehammer, Norway Not yet recruiting Anette Huuse Farmen, MD PhD +4792201208 [email protected]
Nordmøre and Romsdal Regional Hospital | Molde, Norway Not yet recruiting Åse Hagen Morsund, MD, PhD +4747756360 [email protected]
Helse Nord Trøndelag Trust | Namsos, Norway Not yet recruiting Stephan Schüler, MD +4774215535 stephan.schü[email protected]
Oslo University Hospital | Oslo, 0424, Norway Recruiting Anne Hege Aamodt, MD PhD +4723074976 [email protected] Morten C Moe, MD PhD Prof Principal Investigator Øystein K Jørstad, MD Sub-Investigator Kristian L Kraglund, MD PhD Sub-Investigator
Telemark Hospital Trust | Skien, Norway Not yet recruiting Håkon Tobro, MD +4797024796 [email protected]
Stavanger University Hospital | Stavanger, Norway Not yet recruiting Martin Kurz, Prof +47 47246847 [email protected]
University Hospital of North Norway, Tromsø | Tromsø, Norway Not yet recruiting Stein-Harald Johnsen, A/Prof MD +4792864490 [email protected]
St Olav University Hospital | Trondheim, Norway Not yet recruiting Hanne Ellekjær, MD, PhD +47 41562687 [email protected]
Vestfold Hospital Trust | Tønsberg, Norway Not yet recruiting Kristian Jenssen, MD +47 33 34 20 00 [email protected]
Centro Hospitalar Universitário de São João | Porto, Portugal Not yet recruiting Ricardo Soares Reis +351 22 551 2100 [email protected]
Karolinska University Hospital | Stockholm, Sweden Not yet recruiting Michael Mazya, MD PhD +46709720277 [email protected]
Location Countries

Belgium

Denmark

Finland

Ireland

Lithuania

Norway

Portugal

Sweden

Verification Date

2021-03-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Oslo University Hospital

Investigator Full Name: Anne Hege Aamodt

Investigator Title: Senior Consultant, MD, PhD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Tenecteplase

Type: Active Comparator

Description: The total dose of tenecteplase is 0.25 mg/kg body weight, maximum 25 mg. The total dose will be given as an intravenous bolus

Label: acetylsalicylic acid

Type: Active Comparator

Description: one tablet of aspirin 300 mg Other Name: Aspirin

Acronym TenCRAOS
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: 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 randomisation). 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.

Primary Purpose: Treatment

Masking: Single (Participant)

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