TENecteplase in Central Retinal Artery Occlusion Stuy (TenCRAOS)

NCT ID: NCT04526951

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-30
• Study Completion Date: 2025-06-20

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.

Conditions

Central Retinal Artery Occlusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tenecteplase

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

Group Type: ACTIVE_COMPARATOR

Intravenous injection of Tenecteplase and one dose of placebo tablet

Intervention Type: DRUG

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

acetylsalicylic acid

one tablet of aspirin 300 mg Other Name: Aspirin

Group Type: ACTIVE_COMPARATOR

One tablet of Acetylsalicylic Acid and one dose of IV placebo

Intervention Type: DRUG

300 mg Acetylsalisylic acid

Interventions

Intravenous injection of Tenecteplase and one dose of placebo tablet

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

Intervention Type: DRUG

One tablet of Acetylsalicylic Acid and one dose of IV placebo

300 mg Acetylsalisylic acid

Intervention Type: DRUG

Other Intervention Names

Metalyse; 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. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anne Hege Aamodt

Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Antwerp

Antwerp, , Belgium

University Hospital Leuven

Leuven, , Belgium

Aarhus University Hospital

Aarhus, , Denmark

Bispebjerg University Hospital

Copenhagen, , Denmark

Rigshospitalet University Hospital

Copenhagen, , Denmark

Helsinki University Hospital

Helsinki, , Finland

Turku University Hospital

Turku, , Finland

Kauno Klinikos Kaunas

Kaunas, , Lithuania

Vilnius University Hospital

Vilnius, , Lithuania

Haukeland University Hospital

Bergen, , Norway

Vestre Viken Hospital Trust Drammen

Drammen, , Norway

Østfold Hospital Trust Kalnes, Dept of Ophthalmology

Grålum, , Norway

Helse Nord Trøndelag Trust

Namsos, , Norway

Oslo University Hospital

Oslo, , Norway

Telemark Hospital Trust

Skien, , Norway

St Olav University Hospital

Trondheim, , Norway

Vestfold Hospital Trust

Tønsberg, , Norway

Karolinska University Hospital

Stockholm, , Sweden

Countries

Belgium; Denmark; Finland; Lithuania; Norway; Sweden

Other Identifiers

2018-002546-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2019/327

Identifier Type: OTHER

Identifier Source: secondary_id

2024-517606-29-00

Identifier Type: CTIS

Identifier Source: secondary_id

Oslo UH

Identifier Type: -

Identifier Source: org_study_id