TENecteplase in Central Retinal Artery Occlusion Stuy (TenCRAOS) (TenCRAOS)

September 26, 2025 updated by: Anne Hege Aamodt, Oslo University Hospital

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.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • University Hospital Antwerp
      • Leuven, Belgium, 3000
        • University Hospital Leuven
  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital
      • Copenhagen, Denmark
        • Bispebjerg University Hospital
      • Copenhagen, Denmark
        • Rigshospitalet University Hospital
  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
      • Turku, Finland
        • Turku University Hospital
  • Lithuania
      • Kaunas, Lithuania
        • Kauno Klinikos Kaunas
      • Vilnius, Lithuania
        • Vilnius University Hospital
  • Norway
      • Bergen, Norway
        • Haukeland University Hospital
      • Drammen, Norway
        • Vestre Viken Hospital Trust Drammen
      • Grålum, Norway
        • Østfold Hospital Trust Kalnes, Dept of Ophthalmology
      • Namsos, Norway
        • Helse Nord Trøndelag Trust
      • Oslo, Norway, 0424
        • Oslo University Hospital
      • Skien, Norway
        • Telemark Hospital Trust
      • Trondheim, Norway
        • St Olav University Hospital
      • Tønsberg, Norway
        • Vestfold Hospital Trust
  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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
Drug: 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)
Other Names:
  • Metalyse
Active Comparator: acetylsalicylic acid
one tablet of aspirin 300 mg Other Name: Aspirin
Drug: One tablet of Acetylsalicylic Acid and one dose of IV placebo
300 mg Acetylsalisylic acid
Other Names:
  • Aspirin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
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).
Time Frame: 30 (±5) days
logMAR
30 (±5) days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean score on National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) at 30 (±5) and 90 (±15) days
Time Frame: 30 (±5) and 90 (±15) days
Visual function related quality of life at 30 and 90 days. Measures the dimensions of self-reported vision-targeted health status that are most important for persons who have chronic eye diseases. 100 = best possible, 0 = worst possible
30 (±5) and 90 (±15) days
Mean score on EQ-5D at 30 (±5) and 90 (±15) days
Time Frame: 30 (±5) and 90 (±15) days
Quality of life reported at 30 and 90 days. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
30 (±5) and 90 (±15) days
Proportion of patients with ≤ 0.5 logMAR visual acuity in the affected eye at 30 (±5) and 90 (±15) days.
Time Frame: 30 (±5) and 90 (±15) days
logMAR
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.
Time Frame: 30 (±5) and 90 (±15) days
logMAR
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
Time Frame: 30 (±5) and 90 (±15) days
logMAR
30 (±5) and 90 (±15) days
Number of test points seen (of 100) on monocular Esterman perimetry at 30 (±5) and 90 (±15) days
Time Frame: 30 (±5) and 90 (±15) days
Number of test points
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.
Time Frame: 24 hours
DWI lesions
24 hours
National Institutes of Health Stroke Scale score (NIHSS) at 24hrs and discharge.
Time Frame: 24 hours
NIHSS score
24 hours
Modified Rankin Scale score (mRS) at discharge, 30 (±5) and 90 days (±15) days.
Time Frame: Discharge, 30 (±5) and 90 days (±15) days.
mRS score
Discharge, 30 (±5) and 90 days (±15) days.
Presence of ocular neovascularisation at 30 (±5) and 90 (±15) days
Time Frame: 30 (±5) and 90 (±15) days
presence
30 (±5) and 90 (±15) days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause and stroke-related death at discharge, 30 (±5) and 90 (±15) days.
Time Frame: Discharge assessed up to 7 days , 30 (±5) and 90 (±15) days
Mortality
Discharge assessed up to 7 days , 30 (±5) and 90 (±15) days
Proportion of patients with any intracranial haemorrhage at 24 hrs
Time Frame: 24 hours
Intracranial haemorrhage
24 hours
Proportion of patients with symptomatic intracranial haemorrhage until discharge.
Time Frame: at discharge, assessed up to 7 days
Symptomatic intracranial haemorrhage
at discharge, assessed up to 7 days
Proportion of patients with complications such as systemic bleeding at 24 hrs, discharge and 30 (±5) days
Time Frame: 24 hours, at discharge assessed up to 7 days and 30 (±5) days
Systemic bleeding
24 hours, at discharge assessed up to 7 days and 30 (±5) days
Other serious adverse events
Time Frame: 24 hours, at discharge, 30 (±5) days and 90 days (±15) days.
Frequency of serious adverse events
24 hours, at discharge, 30 (±5) days and 90 days (±15) days.
Occurrence of adverse events
Time Frame: 24 hours, at discharge assessed up to 7 days, 30 (±5) days and 90 days (±15) days.
Frequency of adverse events
24 hours, at discharge assessed up to 7 days, 30 (±5) days and 90 days (±15) days.
Retrobulbar spot sign detection using Duplex/Doppler ultrasound at baseline, point-of-care ultrasound (POCUS)
Time Frame: 30 (±5) and 90 (±15) days
Frequency of retrobulbar spot sign
30 (±5) and 90 (±15) days
Retrobulbar spot sign and central retinal artery recanalisation using Duplex/Doppler ultrasound at 24h and discharge
Time Frame: 24 hours and at discharge assessed up to 7 days
Frequency of retrobulbar spot sign
24 hours and at discharge assessed up to 7 days
Macular optical coherence tomography (OCT) volume scans and macular OCT angiography (OCT-A) at 30 and 90 days
Time Frame: 30 (±5) and 90 (±15) days
OCT measures
30 (±5) and 90 (±15) days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Oslo UH
  • 2018-002546-36 (EudraCT Number)
  • 2019/327 (Other Identifier: Ethics Committee in Norway)
  • 2024-517606-29-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is a plan to share data with the THEIA trial and REVISION trial for IPD meta analysis

IPD Sharing Time Frame

Protocol is planned to be published in peer-reviewed journal in 2023

IPD Sharing Access Criteria

Protocol is planned to be published in peer-reviewed journal in 2023 and will be available at the journal site

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

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