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Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant

NCT07621796 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2026-06-02

No results posted yet for this 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.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

Intravenous tenecteplase (TNK)

Intravenous administration of tenecteplase (TNK) at 0.25 mg/kg for a maximum dose of 25 mg.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Shadi Yaghi, MD · Hackensack Meridian Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2032-01-30
Completion
2032-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07621796 on ClinicalTrials.gov