Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04526951
Registration number
NCT04526951
Ethics application status
Date submitted
20/08/2020
Date registered
26/08/2020
Date last updated
5/01/2023
Titles & IDs
Public title
TENecteplase in Central Retinal Artery Occlusion Stuy (TenCRAOS)
Query!
Scientific title
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.
Query!
Secondary ID [1]
0
0
2018-002546-36
Query!
Secondary ID [2]
0
0
Oslo UH
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
TenCRAOS
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Central Retinal Artery Occlusion
0
0
Query!
Condition category
Condition code
Eye
0
0
0
0
Query!
Diseases / disorders of the eye
Query!
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Intravenous injection of Tenecteplase and one dose of placebo tablet
Treatment: Drugs - One tablet of Acetylsalicylic Acid and one dose of IV placebo
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
Active Comparator: acetylsalicylic acid - one tablet of aspirin 300 mg Other Name: Aspirin
Treatment: Drugs: 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)
Treatment: Drugs: One tablet of Acetylsalicylic Acid and one dose of IV placebo
300 mg Acetylsalisylic acid
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
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).
Query!
Assessment method [1]
0
0
logMAR
Query!
Timepoint [1]
0
0
30 (±5) days
Query!
Secondary outcome [1]
0
0
Proportion of patients with = 0.5 logMAR visual acuity in the affected eye at 30 (±5) and 90 (±15) days.
Query!
Assessment method [1]
0
0
logMAR
Query!
Timepoint [1]
0
0
30 (±5) and 90 (±15) days
Query!
Secondary outcome [2]
0
0
Mean improvement in logMAR visual acuity in the affected eye from baseline to 30 (±5) and 90 (±15) days.
Query!
Assessment method [2]
0
0
logMAR
Query!
Timepoint [2]
0
0
30 (±5) and 90 (±15) days
Query!
Secondary outcome [3]
0
0
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
Query!
Assessment method [3]
0
0
logMAR
Query!
Timepoint [3]
0
0
30 (±5) and 90 (±15) days
Query!
Secondary outcome [4]
0
0
Number of test points seen (of 100) on monocular Esterman perimetry at 30 (±5) and 90 (±15) days
Query!
Assessment method [4]
0
0
Number of test points
Query!
Timepoint [4]
0
0
30 (±5) and 90 (±15) days
Query!
Secondary outcome [5]
0
0
Acute ischemic lesions on follow-up on diffusion-weighted (DWI) MRI or on brain CT at baseline and 24hrs.
Query!
Assessment method [5]
0
0
DWI lesions
Query!
Timepoint [5]
0
0
24 hours
Query!
Secondary outcome [6]
0
0
National Institutes of Health Stroke Scale score (NIHSS) at 24hrs and discharge.
Query!
Assessment method [6]
0
0
NIHSS score
Query!
Timepoint [6]
0
0
24 hours
Query!
Secondary outcome [7]
0
0
Modified Rankin Scale score (mRS) at discharge, 30 (±5) and 90 days (±15) days.
Query!
Assessment method [7]
0
0
mRS score
Query!
Timepoint [7]
0
0
Discharge, 30 (±5) and 90 days (±15) days.
Query!
Secondary outcome [8]
0
0
Mean score on National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) at 30 (±5) and 90 (±15) days
Query!
Assessment method [8]
0
0
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
Query!
Timepoint [8]
0
0
30 (±5) and 90 (±15) days
Query!
Secondary outcome [9]
0
0
Mean score on EQ-5D at 30 (±5) and 90 (±15) days
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
30 (±5) and 90 (±15) days
Query!
Secondary outcome [10]
0
0
Presence of ocular neovascularisation at 30 (±5) and 90 (±15) days
Query!
Assessment method [10]
0
0
presence
Query!
Timepoint [10]
0
0
30 (±5) and 90 (±15) days
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
30/10/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/05/2024
Query!
Actual
Query!
Sample size
Target
78
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
St Vincent's Hospital Melbourne - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
- Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
Austria
Query!
State/province [1]
0
0
Salzburg
Query!
Country [2]
0
0
Belgium
Query!
State/province [2]
0
0
Anderlecht
Query!
Country [3]
0
0
Belgium
Query!
State/province [3]
0
0
Antwerp
Query!
Country [4]
0
0
Belgium
Query!
State/province [4]
0
0
Brussel
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Leuven
Query!
Country [6]
0
0
Denmark
Query!
State/province [6]
0
0
Aarhus
Query!
Country [7]
0
0
Denmark
Query!
State/province [7]
0
0
Copenhagen
Query!
Country [8]
0
0
Finland
Query!
State/province [8]
0
0
Helsinki
Query!
Country [9]
0
0
Finland
Query!
State/province [9]
0
0
Turku
Query!
Country [10]
0
0
Ireland
Query!
State/province [10]
0
0
Dublin
Query!
Country [11]
0
0
Ireland
Query!
State/province [11]
0
0
Galway
Query!
Country [12]
0
0
Ireland
Query!
State/province [12]
0
0
Limerick
Query!
Country [13]
0
0
Ireland
Query!
State/province [13]
0
0
Waterford
Query!
Country [14]
0
0
Lithuania
Query!
State/province [14]
0
0
Kaunas
Query!
Country [15]
0
0
Lithuania
Query!
State/province [15]
0
0
Vilnius
Query!
Country [16]
0
0
Norway
Query!
State/province [16]
0
0
Arendal
Query!
Country [17]
0
0
Norway
Query!
State/province [17]
0
0
Bergen
Query!
Country [18]
0
0
Norway
Query!
State/province [18]
0
0
Drammen
Query!
Country [19]
0
0
Norway
Query!
State/province [19]
0
0
Grålum
Query!
Country [20]
0
0
Norway
Query!
State/province [20]
0
0
Lillehammer
Query!
Country [21]
0
0
Norway
Query!
State/province [21]
0
0
Molde
Query!
Country [22]
0
0
Norway
Query!
State/province [22]
0
0
Namsos
Query!
Country [23]
0
0
Norway
Query!
State/province [23]
0
0
Oslo
Query!
Country [24]
0
0
Norway
Query!
State/province [24]
0
0
Skien
Query!
Country [25]
0
0
Norway
Query!
State/province [25]
0
0
Stavanger
Query!
Country [26]
0
0
Norway
Query!
State/province [26]
0
0
Tromsø
Query!
Country [27]
0
0
Norway
Query!
State/province [27]
0
0
Trondheim
Query!
Country [28]
0
0
Norway
Query!
State/province [28]
0
0
Tønsberg
Query!
Country [29]
0
0
Sweden
Query!
State/province [29]
0
0
Stockholm
Query!
Country [30]
0
0
Sweden
Query!
State/province [30]
0
0
Sundsvall
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Oslo University Hospital
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04526951
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Anne Hege Aamodt
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+47 23074976
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04526951
Download to PDF