Thrombolytic Agent

Tenecteplase for Stroke (DoubleDoseTNK Trial)

Houston, TX

Phase 1

Waitlist Available

Research Sponsored by Memorial Hermann Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Signs and symptoms suggestive of acute ischemic stroke

Age > 18 and < 80 years

Must not have

Patients with LVO or MeVO for whom EVT is intended at any time before the second dose of TENECTEPLASE

Known bleeding diathesis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 36 hours of enrollment (2nd dose of tenecteplase)

Awards & highlights

No Placebo-Only Group

Summary

This trial will give a second dose of a medication called Intravenous Tenecteplase to patients who have had a stroke and did not improve after the first dose. The study will include 20

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Who is the study for?

This trial is for acute ischemic stroke patients who haven't improved after a first dose of Tenecteplase within 3 hours from symptom onset, have an NIHSS score over 6, and can receive a second dose within 4.5 hours. They must not show bleeding on a CT scan and meet standard criteria for Tenecteplase.Check my eligibility

What is being tested?

The study tests the safety of giving a second dose of Tenecteplase to stroke patients who don't respond to the initial treatment. It measures severe bleeding risks and changes in neurological status immediately after treatment and at follow-up.See study design

What are the potential side effects?

Potential side effects include symptomatic intracranial hemorrhage (brain bleed with symptoms) or serious systemic bleeding within 36 hours post-treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am showing signs of a possible stroke.

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I am between 18 and 80 years old.

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My brain scans show no bleeding and a good health score.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for a clot removal procedure before my second dose of TENECTEPLASE.

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I have a bleeding disorder.

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I don't have bleeding disorders and haven't taken warfarin or had an INR > 1.5 recently.

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I was independent in daily activities before my stroke.

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I am currently experiencing internal bleeding.

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I do not have undiagnosed cognitive issues or known brain vessel disease.

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I am currently on medication to reduce amyloid in my body.

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I have had a bleeding stroke in the past.

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I have taken more than one blood thinner in the last 48 hours.

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I might have an infection in my heart.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 36 hours of enrollment (2nd dose of tenecteplase)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 36 hours of enrollment (2nd dose of tenecteplase)

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 36 hours of enrollment (2nd dose of tenecteplase) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

symptomatic intracerebral hemorrhage or major systemic bleeding

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients receiving double dose TNKExperimental Treatment1 Intervention

We will give a second dose of IV TNK to patients receiving the initial TNK dose within 3 hrs of LKN, have a baseline NIHSS \> 6, and who do not clinically improve within 45 minutes of the first dose, or who improve but then deteriorate, and can still be treated within 4.5 hours from LKN. Patients will require a second CT scan to rule out any bleeding, and meet the usual inclusion and exclusion criteria for TNK treatment, before the second dose which must be given within 4.5 hrs of LKN. Both TNK doses will be 0.25 mg/kg. The initial TNK dose may be given on the MSU or ED, and the second dose in the ED.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)

2009

Completed Phase 2

~20

0 / 13Eligibility criteria met