2025-521762-99-00
Not yet recruiting
Phase 3
Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants – a multicentre randomised placebo-controlled clinical trial
University Medical Center Hamburg-Eppendorf10 sites in 1 country668 target enrollmentStarted: December 16, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- University Medical Center Hamburg-Eppendorf
- Enrollment
- 668
- Locations
- 10
- Primary Endpoint
- Functional outcome (modified Rankin Scale, mRS) 90 days after randomisation
Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion 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.
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Functional outcome (modified Rankin Scale, mRS) 90 days after randomisation
Functional outcome (modified Rankin Scale, mRS) 90 days after randomisation
Secondary Outcomes
- Safety Endpoint: Major haemorrhage (ISTH) within 72 hours
- Safety Endpoint: Orolingual angioedema within 4 hours
- Safety Endpoint: Death or dependency (mRS score 4–6) after 90 days
- Safety Endpoint: All-cause mortality after 90 days
- Safety Endpoint: Time to death right-censored at 90 days
- Efficacy Endpoint: Nondisabled (mRS score ≤ 1) functional outcome after 90 days
- Efficacy Endpoint: Independent (mRS score ≤ 2) functional outcome after 90 days
- Efficacy Endpoint: Early neurological deficit (National Institutes of Health stroke scale) after 24 hours
- Efficacy Endpoint: Health-related quality of life (PROMIS®-10) after 90 days
- Efficacy Endpoint: Cognitive impairment (Montreal Cognitive Assessment) after 90 days
- Safety Endpoint: Any intracranial haemorrhage within 36 hours
- Safety Endpoint: Symptomatic intracranial haemorrhage within 36 hours (mSITS-MOST)
- Safety Endpoint: Fatal intracranial haemorrhage within 30 days
Investigators
Senior Physician at the Department of Neurology
Scientific
University Medical Center Hamburg-Eppendorf
Study Sites (10)
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