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

Part of paid clinical trials in Neptune City, New Jersey.

Sponsor
Hackensack Meridian Health
Study ID
NCT07621796
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 1, 2027
Status verified
May 2026
Primary completion
Jan 30, 2032
Completion
Jan 30, 2032

Study Design

Enrollment
660 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intravenous Tenecteplase (TNK)
    Intravenous TNK 0.25 mg/Kg
  • Placebo Comparator: Placebo
    normal saline placebo

Primary Outcome Measure

Efficacy of intravenous Tenecteplase (TNK) [ Time Frame: 90 days post administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hackensack Meridian Health - Jersey Shore University Medical CenterNeptune CityNew Jersey07753
Danielle Dubenezic
[email protected]
732-897-8175
Shadi Yaghi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Neptune City, NJ

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Hackensack Meridian Health - Jersey Shore University Medical Center· Neptune City, NJ

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