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NCT07621796 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant
A Phase 3 study, sponsored by Hackensack Meridian Health.
- Not yet
- Registry status
- Phase 3
- Development phase
- 660
- Enrollment target
NCT07621796 is a Phase 3 study that has not yet begun recruiting, run by Hackensack Meridian Health. The registered enrollment target is 660 participants.
The verdict
NCT07621796, a Phase 3 study, has not yet begun recruiting, sponsored by Hackensack Meridian Health.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 660 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Intravenous tenecteplase (TNK)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2027-01-01 |
| Est. Completion | 2032-01-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07621796
The ClinicalTrials.gov registry entry for NCT07621796 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 660 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hackensack Meridian Health, which has 90 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07621796 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07621796 about?
NCT07621796 is a clinical study titled "Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant". 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 site...
What is the current status of trial NCT07621796?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2027-01-01. Estimated completion is 2032-01-30.
What interventions are being tested in trial NCT07621796?
The interventions under investigation include: Placebo (DRUG), Intravenous tenecteplase (TNK) (DRUG).
Who is sponsoring clinical trial NCT07621796?
This trial is sponsored by Hackensack Meridian Health, which has 90 total clinical trials registered on ClinicalTrials.gov.
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