Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of… (NCT07621796) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant
United States660 participantsStarted 2027-01-01
Plain-language summary
The study will randomize patients with acute ischemic stroke and Direct Oral AntiCoagulants (DOAC) ingestion within 48 hours from enrollment (but otherwise eligible for thrombolysis) to administration of intravenous tenecteplase vs. placebo (1:1).
Participants will be enrolled at NIH StrokeNet sites across the US and followed for 90-days.
The primary aim is to determine the efficacy of intravenous tenecteplase (TNK) vs placebo among acute ischemic stroke patients and to determine the safety of TNK among acute ischemic stroke patients within 4.5 hours of last known well who used DOAC within 48 hours prior to thrombolysis. Efficacy and safety endpoints will be the focus of this proposed Phase III study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults (18 years or older) with a suspected acute ischemic stroke and clearly disabling deficits
* Presenting within 4.5 hours of last known well
* Able to initiate intravenous thrombolysis within 4.5 hours of last known well
* On recent DOAC therapy (dabigatran, apixaban, rivaroxaban, edoxaban) and known last dose taken within 48 hours from thrombolysis.
Exclusion Criteria:
* Current or history of intracerebral hemorrhage
* Non-disabling deficits
* Bleeding disorder (e.g. hemophilia) or advanced liver disease or known INR \> 1.7 within 6 hours
* Use of therapeutic low molecular weight heparin or therapeutic dose heparin with elevated PTT
* ASPECTS \< 6 or clear hypodensity on CT suggestive of completed infarct
* Advanced kidney disease (eGFR \< 30 ml/min)
* Known or suspected aortic dissection
* Known or high suspicion for infective endocarditis
* Surgery within 2 weeks
* Intracranial or intraspinal surgery within 3 months
* Active internal bleeding or gastrointestinal or urinary tract hemorrhage within 3 weeks
* Intracranial neoplasm, arterio-venous malformation, or cavernous malformation
* Major head trauma or ischemic stroke within 3 months
* Known thrombocytopenia (platelets \< 100,000)
* Planned endovascular treatment within 30 minutes of study drug administration (i.e., consent, randomization and administration of study drug must occur at least 30 minutes prior to groin puncture; standard care is not to be delayed and patients in whom endovascu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of intravenous Tenecteplase (TNK)
Timeframe: 90 days post administration
2
Safety of intravenous TNK
Timeframe: within 36 hours from thrombolysis administration