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New treatment option for Stroke
Official title Thrombolysis in Factor Xa-inhibitors Trial
ClinicalTrials.gov ID: NCT06878066
What this study is testing
What is thrombolysis therapy?
thrombolysis therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for stroke.
Also referred to as Alteplase, Tenecteplase.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study looks at whether stroke patients who take FXa inhibitors (a type of blood thinner) can safely receive clot-busting treatment (IVT). IVT is a common emergency treatment for stroke, but current guidelines say it should not be given to people who have taken FXa inhibitors in the last 48 hours.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant must be 18 years of age or older.
- Ingestion of FXa inhibitors within the last 48 hours of symptom onset (or ongoing prescription of FXa inhibitor if unknown)
- Clinical diagnosis of AIS with disabling neurological deficit
- Presenting within 4.5 h of symptom onset or after awakening with symptoms of AIS with FLAIR-DWI mismatch on MRI as judged by the (neuro-) radiologist.
- Informed consent
You likely can't join if
- Endovascular treatment eligible patients with isolated large vessel occlusion of the intracranial internal carotid artery (ICA), the M1 segment of...
- Systolic BP \>185 mmHg or diastolic BP \>110 mmHg despite antihypertensive treatment.
- Known bleeding diathesis; manifest or recent severe bleeding; significant bleeding disorder last 6 months.
- Arterial puncture at a non-compressible site; biopsy or lumbar puncture \<7 days; major surgery, traumatic external heart massage, obstetrical...
- Any condition that, in the opinion of the treating physician, puts a patient at risk if treated with thrombolysis (i.e. signs of cerebral hemorrhage...
- Use of a) direct thrombin (II) inhibitor (Dabigatran) or b) warfarin with an INR ≥1.8; c) heparin \<48 h; d) treatment dose of LMWH \<24 h...
See the full eligibility criteria
- Participant must be 18 years of age or older.
- Ingestion of FXa inhibitors within the last 48 hours of symptom onset (or ongoing prescription of FXa inhibitor if unknown)
- Clinical diagnosis of AIS with disabling neurological deficit
- Presenting within 4.5 h of symptom onset or after awakening with symptoms of AIS with FLAIR-DWI mismatch on MRI as judged by the (neuro-) radiologist.
- Informed consent
- Endovascular treatment eligible patients with isolated large vessel occlusion of the intracranial internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or both confirmed by CT or MR...
- Systolic BP \>185 mmHg or diastolic BP \>110 mmHg despite antihypertensive treatment.
- Known bleeding diathesis; manifest or recent severe bleeding; significant bleeding disorder last 6 months.
- Arterial puncture at a non-compressible site; biopsy or lumbar puncture \<7 days; major surgery, traumatic external heart massage, obstetrical delivery or serious trauma \<14 days; history of intracranial haemorrhage...
- Any condition that, in the opinion of the treating physician, puts a patient at risk if treated with thrombolysis (i.e. signs of cerebral hemorrhage, known cerebral amyloid angiopathy, CT with signs of early ischemia...
- Use of a) direct thrombin (II) inhibitor (Dabigatran) or b) warfarin with an INR ≥1.8; c) heparin \<48 h; d) treatment dose of LMWH \<24 h. Prior/Concurrent Clinical Study Experience
- Hypersensitivity to Alteplase or Tenecteplase
The study team makes the final eligibility decision.
Where it's taking place
- Bærum, Gjettum, Norway
- Ålesund, Norway
- Bergen, Norway
- Drammen, Norway
- Grålum, Norway
- Kristiansand, Norway
- Lillehammer, Norway
- Oslo, Norway
- Stavanger, Norway
- Tromsø, Norway
- Trondheim, Norway
- Tønsberg, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bærum, Gjettum, Norway; Ålesund, Norway; Bergen, Norway; Drammen, Norway; Grålum, Norway; Kristiansand, Norway and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.