Printed from Voxsanity (voxsanity.com.au) — NCT06878066 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Stroke Trial, Recruiting
NCT06878066
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are 18 years of age or older.
- People who have taken a Factor Xa blood thinner (such as rivaroxaban, apixaban, or edoxaban) within the last 48 hours before their stroke symptoms started, or who have an ongoing prescription for one of these medications if the exact timing is unknown.
- People who have been diagnosed with an acute ischaemic stroke (a stroke caused by a blood clot) that is causing significant difficulty with normal activities or movement.
- People who arrive for treatment within 4.5 hours of their stroke symptoms starting, or who woke up with stroke symptoms and have a specific pattern on a brain MRI scan (called a FLAIR-DWI mismatch) as assessed by a radiologist.
- People who are able to give informed consent to participate.
Who may not be able to join:
- People whose stroke is caused by a large blockage in certain major brain arteries, where a procedure to remove the clot through the groin is expected to be ready to begin within 30 minutes.
- People with very high blood pressure (above 185/110 mmHg) that has not come down with blood pressure medication.
- People with a known bleeding disorder, an active or recent serious bleed, or a significant bleeding problem in the past 6 months.
- People who have had any of the following: a needle inserted into an artery at a site that cannot be pressed to stop bleeding; a tissue biopsy or spinal tap within the last 7 days; major surgery, chest compressions during resuscitation, childbirth, or serious physical injury within the last 14 days; a previous bleed in the brain; a stroke within the last 2 months; brain surgery within the last 2 months; a serious head injury within the last 2 months; inflammation around the heart (pericarditis); blood poisoning (sepsis); a bacterial heart infection; inflammation of the pancreas; a cancer that carries a high risk of bleeding; any serious medical condition likely to be affected by the treatment (such as a tear in the main blood vessel from the heart); or a pre-existing significant neurological or psychiatric condition.
- People where the treating doctor judges that receiving a clot-dissolving medication would carry a serious risk of harm — for example, if there are signs of bleeding in the brain, a known condition called cerebral amyloid angiopathy, or a brain scan showing a large area of early stroke damage (confirm with trial site).
- People currently taking the blood thinner dabigatran; people taking warfarin with a blood test result (INR) of 1.8 or higher; people who have received heparin (a blood thinner given by injection) within the last 48 hours; or people who have received a treatment dose of low molecular weight heparin within the last 24 hours.
- People who have a known allergy or hypersensitivity to the medications alteplase or tenecteplase (the clot-dissolving drugs used in this trial).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Håkon Ihle-Hansen, MD, PhD, Dept. of Medicine, Baerum Hospital
Phone: +47 92821843
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Phase 3
Sponsor
Guri Hagberg
Registry
ClinicalTrials.gov
Start date
14 March 2025
Est. completion
31 December 2028
Where this trial is recruiting
🇳🇴 Norway
Primary endpoints
Early neurological improvement (ENI)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.