Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant (NCT07621796)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (19 items).
Location: Hackensack Meridian Health - Jersey Shore University Medical Center — Neptune City, New Jersey
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Hackensack Meridian Health - Jersey Shore University Medical Center — Neptune City, New Jersey
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.