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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: Clinical Trial Phase 3 study, sponsored by Hackensack Meridian Health.
NCT07621796 is a Phase 3 study that has not yet begun recruiting, run by Hackensack Meridian Health. The registered enrollment target is 660 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Determine the efficacy of intravenous Tenecteplase (TNK) vs placebo among acute ischemic stroke patients within 4.5 hours of their last known well who used DOAC within 48 hours prior to thrombolysis. The primary endpoint is 90-day modified Rankin Scale (mRS). Modified Rankin Scale is a 6 point tool to assess disability with 0 being no disability and 6 being death.
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 |
What is known before NCT07621796 opens enrollment
NCT07621796 is an interventional study that assigns participants to a tested intervention. The registered 660 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07621796 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07621796's enrollment target sits among peer trials
660 556th of 2000 higher than 1,440 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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