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NOT YET RECRUITING
NCT07621796
PHASE3

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

Sponsor: Hackensack Meridian Health

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant (ESTER-DOAC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

660

Start Date

2027-01-01

Completion Date

2032-01-30

Last Updated

2026-06-02

Healthy Volunteers

No

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

Locations (1)

Hackensack Meridian Health - Jersey Shore University Medical Center

Neptune City, New Jersey, United States