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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)
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.
Secondary ID [1] 0 0
2018-002546-36
Secondary ID [2] 0 0
Oslo UH
Universal Trial Number (UTN)
Trial acronym
TenCRAOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central Retinal Artery Occlusion 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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).
Timepoint [1] 0 0
30 (±5) days
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.
Timepoint [1] 0 0
30 (±5) and 90 (±15) days
Secondary outcome [2] 0 0
Mean improvement in logMAR visual acuity in the affected eye from baseline to 30 (±5) and 90 (±15) days.
Timepoint [2] 0 0
30 (±5) and 90 (±15) days
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
Timepoint [3] 0 0
30 (±5) and 90 (±15) days
Secondary outcome [4] 0 0
Number of test points seen (of 100) on monocular Esterman perimetry at 30 (±5) and 90 (±15) days
Timepoint [4] 0 0
30 (±5) and 90 (±15) days
Secondary outcome [5] 0 0
Acute ischemic lesions on follow-up on diffusion-weighted (DWI) MRI or on brain CT at baseline and 24hrs.
Timepoint [5] 0 0
24 hours
Secondary outcome [6] 0 0
National Institutes of Health Stroke Scale score (NIHSS) at 24hrs and discharge.
Timepoint [6] 0 0
24 hours
Secondary outcome [7] 0 0
Modified Rankin Scale score (mRS) at discharge, 30 (±5) and 90 days (±15) days.
Timepoint [7] 0 0
Discharge, 30 (±5) and 90 days (±15) days.
Secondary outcome [8] 0 0
Mean score on National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) at 30 (±5) and 90 (±15) days
Timepoint [8] 0 0
30 (±5) and 90 (±15) days
Secondary outcome [9] 0 0
Mean score on EQ-5D at 30 (±5) and 90 (±15) days
Timepoint [9] 0 0
30 (±5) and 90 (±15) days
Secondary outcome [10] 0 0
Presence of ocular neovascularisation at 30 (±5) and 90 (±15) days
Timepoint [10] 0 0
30 (±5) and 90 (±15) days

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2024
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Salzburg
Country [2] 0 0
Belgium
State/province [2] 0 0
Anderlecht
Country [3] 0 0
Belgium
State/province [3] 0 0
Antwerp
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussel
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Denmark
State/province [6] 0 0
Aarhus
Country [7] 0 0
Denmark
State/province [7] 0 0
Copenhagen
Country [8] 0 0
Finland
State/province [8] 0 0
Helsinki
Country [9] 0 0
Finland
State/province [9] 0 0
Turku
Country [10] 0 0
Ireland
State/province [10] 0 0
Dublin
Country [11] 0 0
Ireland
State/province [11] 0 0
Galway
Country [12] 0 0
Ireland
State/province [12] 0 0
Limerick
Country [13] 0 0
Ireland
State/province [13] 0 0
Waterford
Country [14] 0 0
Lithuania
State/province [14] 0 0
Kaunas
Country [15] 0 0
Lithuania
State/province [15] 0 0
Vilnius
Country [16] 0 0
Norway
State/province [16] 0 0
Arendal
Country [17] 0 0
Norway
State/province [17] 0 0
Bergen
Country [18] 0 0
Norway
State/province [18] 0 0
Drammen
Country [19] 0 0
Norway
State/province [19] 0 0
Grålum
Country [20] 0 0
Norway
State/province [20] 0 0
Lillehammer
Country [21] 0 0
Norway
State/province [21] 0 0
Molde
Country [22] 0 0
Norway
State/province [22] 0 0
Namsos
Country [23] 0 0
Norway
State/province [23] 0 0
Oslo
Country [24] 0 0
Norway
State/province [24] 0 0
Skien
Country [25] 0 0
Norway
State/province [25] 0 0
Stavanger
Country [26] 0 0
Norway
State/province [26] 0 0
Tromsø
Country [27] 0 0
Norway
State/province [27] 0 0
Trondheim
Country [28] 0 0
Norway
State/province [28] 0 0
Tønsberg
Country [29] 0 0
Sweden
State/province [29] 0 0
Stockholm
Country [30] 0 0
Sweden
State/province [30] 0 0
Sundsvall

Funding & Sponsors
Primary sponsor type
Other
Name
Oslo University Hospital
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04526951
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anne Hege Aamodt
Address 0 0
Country 0 0
Phone 0 0
+47 23074976
Fax 0 0
Email 0 0
a.h.aamodt@medisin.uio.no
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04526951