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Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants
EU CTIS ID: 2025-521762-99-00
What this study is testing
To assess whether intravenous thrombolysis with tenecteplase 0.25 mg/kg improves functional outcome after acute ischemic stroke in patients taking direct oral anticoagulants compared to placebo.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Clinical diagnosis of acute stroke with disabling deficit
- National Institutes of Health Stroke Scale (NIHSS) score at least 2
- Recent intake (within 48 hours prior to enrolment) of a direct oral anticoagulant (apixaban, rivaroxaban, edoxaban, or dabigatran)
- No evidence of any intracranial haemorrhage on cerebral imaging (CT or MRI) performed after stroke onset and no earlier than 60 minutes before enrolment
- Stroke symptoms not known to have been present for > 6 h
You likely can't join if
- Contraindication to intravenous thrombolysis, except DOAC therapy
- Reversal or planned reversal of anticoagulation with idarucizumab or andexanet alfa
- Concomitant therapy with antithrombotic medications, except DOACs
- Anticipated stenting of cervical or intracranial artery within 12 hours
- Anticipated coronary angioplasty within 12 hours
- Any anticipated surgical intervention within 12 hours
See the full eligibility criteria
- Age ≥ 18 years
- Clinical diagnosis of acute stroke with disabling deficit
- National Institutes of Health Stroke Scale (NIHSS) score at least 2
- Recent intake (within 48 hours prior to enrolment) of a direct oral anticoagulant (apixaban, rivaroxaban, edoxaban, or dabigatran)
- No evidence of any intracranial haemorrhage on cerebral imaging (CT or MRI) performed after stroke onset and no earlier than 60 minutes before enrolment
- Stroke symptoms not known to have been present for > 6 h
- For patients not known to have been awake and without acute stroke symptoms within 4.5 hours prior to enrolment, additional imaging criteria must be satisfied: a) If stroke symptoms are known to have been present for > 4.5 h (late time window): core/penumbra mismatch on MR or CT perfusion imaging; b) If stroke symptoms are not known to have been present for > 4.5 h (unknown time window): core/penumbra mismatch on MR or CT perfusion imaging; or DWI/FLAIR mismatch on MR imaging.
- Contraindication to intravenous thrombolysis, except DOAC therapy
- Reversal or planned reversal of anticoagulation with idarucizumab or andexanet alfa
- Concomitant therapy with antithrombotic medications, except DOACs
- Anticipated stenting of cervical or intracranial artery within 12 hours
- Anticipated coronary angioplasty within 12 hours
- Any anticipated surgical intervention within 12 hours
- Significant pre-stroke disability (mRS > 3)
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.