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Status:

COMPLETED

TENecteplase in Central Retinal Artery Occlusion Stuy (TenCRAOS)

Lead Sponsor:

Oslo University Hospital

Conditions:

Central Retinal Artery Occlusion

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 (...

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 arter...

Eligibility Criteria

Inclusion

  • Non-arteritic central retinal artery occlusion with ≥ 1.0 logMAR visual acuitiy and symptoms lasting less than 4.5 hours.
  • Ability to administer the Investigator Medicinal Product (IMP) within 4.5 hours of symptom onset.
  • Age ≥18 years.
  • Informed written consent of the patient.
  • 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

  • Other active intervention targeting CRAO.
  • 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).
  • Systemic diseases; severe general diseases, systemic arterial hypertension (blood pressure \>185/110 mmHg), despite medical therapy, or clinical suspicion of acute systemic inflammation.
  • Presence of intracranial haemorrhage on brain MRI/CT.
  • 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.
  • No willingness and ability of the patient to participate in all follow-up examinations.
  • Pregnancy (if suspicion of pregnancy s-hCG or u-hCG must be negative).
  • Allergy or intolerance to any ingredients of IMP or placebo or gentamicin.
  • Other conditions / circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, no fixed abode).
  • Significant bleeding disorder either at present or within the past 6 months.
  • Effective oral anticoagulant treatment, eg, warfarin sodium (INR \>1.3).
  • Effective anticoagulant treatment with heparin or low molecular weight heparin the last 48 hours.
  • Any history of central nervous system damage (ie, neoplasm, aneurysm, intracranial or spinal surgery).
  • Known hemorrhagic diathesis.
  • Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with acute myocardial infarction).
  • Recent non-compressible vessel puncture within 2 weeks.
  • Recent trauma to the head or cranium.
  • Prolonged cardiopulmonary resuscitation (\>2 minutes) within the past 2 weeks.
  • Acute pericarditis and/or subacute bacterial endocarditis.
  • Acute pancreatitis.
  • Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis.
  • Active peptic ulceration.
  • Arterial aneurysm and known arterial/venous malformation.
  • Neoplasm with increased bleeding risk.
  • Any known history of hemorrhagic stroke or stroke of unknown origin.
  • Known history of ischemic stroke or transient ischemic attack in the preceding 3 months.
  • Dementia.

Key Trial Info

Start Date :

October 30 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 20 2025

Estimated Enrollment :

81 Patients enrolled

Trial Details

Trial ID

NCT04526951

Start Date

October 30 2020

End Date

June 20 2025

Last Update

September 29 2025

Active Locations (18)

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Page 1 of 5 (18 locations)

1

University Hospital Antwerp

Antwerp, Belgium

2

University Hospital Leuven

Leuven, Belgium, 3000

3

Aarhus University Hospital

Aarhus, Denmark

4

Bispebjerg University Hospital

Copenhagen, Denmark