Study comparing tenecteplase and acetylsalicylic acid in patients with central retinal artery occlusion within 4.

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What is this study about?

This study focuses on central retinal artery occlusion, a condition where blood flow to the eye’s retina becomes blocked, which can cause sudden vision loss. The research compares two different treatments: tenecteplase, a medication given through an intravenous injection, and acetylsalicylic acid (also known as aspirin), which is taken as a tablet.

The purpose of this research is to evaluate how effective tenecteplase is when given within 4.5 hours after the first symptoms of central retinal artery occlusion appear. During the study, participants will receive either tenecteplase with a placebo tablet or acetylsalicylic acid with a placebo injection. Neither the patients nor the doctors will know which treatment each participant receives during the study.

The study will monitor changes in vision over time, particularly focusing on vision improvement after 30 days of treatment. Participants will receive either a single dose of tenecteplase through an intravenous injection or acetylsalicylic acid tablets. Some participants will also receive sodium chloride solution (normal saline) as part of their treatment.

1 Initial vision assessment

Your vision will be tested to confirm central retinal artery occlusion (a blockage in the blood vessel of the eye) and verify that your vision score is at least 1.0 logMAR

The assessment must occur within 4.5 hours from when your symptoms began

2 Medical eligibility check

Your eligibility for the study will be confirmed based on age (must be 18 or older)

If you are a woman who can become pregnant, a pregnancy test may be required

3 Treatment administration

You will receive one of two possible treatments:

Option 1: Tenecteplase (0.25 mg per kg of body weight) given through an intravenous injection, plus an inactive tablet

Option 2: Acetylsalicylic acid (Albyl-E 75 mg) tablet taken by mouth, plus an inactive intravenous solution

Neither you nor your doctor will know which treatment you receive

4 Follow-up vision assessment

Your vision will be tested again after 30 days (plus or minus 5 days)

The test will measure if your vision has improved to a score of 0.7 logMAR or better

Who Can Join the Study?

  • You must have a condition called central retinal artery occlusion (a blockage in the blood vessel that supplies blood to your retina) with significantly reduced vision and symptoms that started less than 4.5 hours ago
  • You must be able to receive the study medication within 4.5 hours from when your symptoms first started
  • You must be at least 18 years old
  • You must be able to provide written informed consent to participate in the study
  • If you are a woman who can become pregnant, you must either:
    • Confirm that you cannot be pregnant at the moment
    • If there is a possibility of pregnancy, have a negative pregnancy test before receiving the study medication

Who Cannot Join the Study?

  • Age below 18 years or above 85 years
  • Presence of any bleeding disorders or active bleeding
  • Recent major surgery within the past 14 days
  • History of stroke in the past 3 months
  • Uncontrolled high blood pressure (blood pressure higher than 185/110 mmHg)
  • Current use of blood thinners (anticoagulants)
  • Pregnancy or breastfeeding
  • Known severe liver or kidney disease
  • Previous allergic reactions to tenecteplase or similar medications
  • Symptoms lasting longer than 4.5 hours
  • Active internal bleeding or history of bleeding in the brain
  • Severe heart disease or recent heart attack
  • Blood sugar levels below 50 mg/dL or above 400 mg/dL
  • Current participation in other clinical trials
  • Inability to provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
Karolinska Institutet Solna Sweden
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
St. Olavs Hospital HF Trondheim Norway
Helse Stavanger HF Stavanger Norway
Region Vaesternorrland Sundsvall Sweden
Sykehuset Innlandet HF Brumunddal Norway
Vestre Viken HF Drammen Norway
Turku University Hospital Turku Finland
Sykehuset Oestfold HF Kalnes Graalum Norway
Rigshospitalet Copenhagen Denmark
Roskilde University Roskilde Denmark
Sykehuset I Vestfold HF Tonsberg Norway
Sxvasnbsc Twhkmrgg Ha Skien Norway
Hjtsh Brcqvm Hp Bergen Norway
Hiznjfzj Ugmpatxezv Cwgkbtt Hwurbxiw Helsinki Finland
Ageqih Upqogzpyay Henfxehm Aarhus Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
30.10.2020
Denmark Denmark
Not yet recruiting
30.10.2020
Finland Finland
Not yet recruiting
30.10.2020
Ireland Ireland
Not yet recruiting
30.10.2020
Norway Norway
Recruiting
30.10.2020
Sweden Sweden
Not yet recruiting
30.10.2020

Trial locations

Tenecteplase (TNK) is a medication used to break up blood clots. In this trial, it is being studied for treating central retinal artery occlusion (CRAO), which is a blockage in the blood vessel that supplies the retina. The medication works by helping to dissolve the clot that is blocking blood flow to the eye.

Aspirin (ASA) is a common blood-thinning medication that helps prevent blood clots from forming. It works by making blood platelets less sticky, which reduces the chance of clots forming in blood vessels. In this trial, it serves as an active comparison treatment for patients with central retinal artery occlusion.

Central Retinal Artery Occlusion – A condition where blood flow through the central retinal artery becomes blocked, cutting off blood supply to the retina. The blockage typically occurs when a blood clot or piece of fatty deposit (embolus) gets lodged in the artery. The retina, which is the light-sensitive tissue at the back of the eye, becomes deprived of oxygen and nutrients. This condition usually develops suddenly and affects one eye at a time. The lack of blood flow causes the retinal cells to become damaged, leading to vision problems in the affected eye. Vision loss typically occurs in the central field of vision while peripheral vision may remain intact.

Trial ID:
2024-517606-29-00
NCT ID:
NCT04526951
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on Alteplase for Vision Recovery in Patients with Acute Central Retinal Artery Occlusion

    Not recruiting

    3 1 1
    Investigated drugs:
    Germany