Tenecteplase Versus Alteplase in Ischemic Stroke Management (TALISMAN) (TALISMAN)

September 22, 2015 updated by: Reza Behrouz, DO

Phase IIb Study Comparing Tenecteplase to Alteplase in Acute Ischemic Stroke Within 3 to 4.5 Hours From Symptom Onset

This is a double-blind parallel arm randomized trial aimed to assess efficacy and safety of intravenous Tenecteplase compared to intravenous Alteplase in eligible patients who present with symptoms of acute ischemic stroke within 3 to 4.5 hours from onset.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Patients presenting with symptoms of acute ischemic stroke (AIS) who present within 3 to 4.5 hours of symptom onset and who meet the inclusion criteria for intravenous (IV) thrombolysis will receive, in a randomized, double-blind fashion, either IV Alteplase at 0.9 mg/kg per standard protocol or IV Tenecteplase at 0.25 mg/kg with saline infusion over one hour. Patients must also have no exclusion criteria for IV thrombolysis within the 3 to 4.5 hour window. The only required imaging is non-contrasted CT of the head. Patients will be monitored according to standard post-thrombolytic care. A CT of the head will be performed at 24 hours based on standard protocol or if there is any neurological change. Neurological function at 24 hours using NIHSS and at 3 months based on modified mRS and the NIHSS.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 to 80 years
  2. Acute neurologic deficit with an NIHSS ≥ 4
  3. Non-enhanced computed tomography (NECT) of the head showing no hemorrhage
  4. Acute ischemic stroke symptoms with onset, or time last known well, clearly defined between 3 and 4.5 hours
  5. Treatment can be initiated within 3 to 4.5 hours from symptom onset

Exclusion Criteria:

  1. Evidence of intracranial hemorrhage on NECT
  2. Clinical suspicion of subarachnoid hemorrhage even with normal NECT
  3. NECT shows hypo-density greater than 1/3 cerebral hemisphere)
  4. History of intracranial hemorrhage/stroke
  5. Uncontrolled HTN: At time treatment begins SBP remains >185 mmHg or DBP remains >110 mmHg despite repeated measurements
  6. Known arteriovenous malformation, neoplasm, or aneurysm
  7. Witnessed seizure at stroke onset
  8. Acute bleeding tendencies
  9. Platelet count <100,000/mm3
  10. Heparin received in prior 48 hours with elevated aPTT
  11. Current use of an anticoagulant (Coumadin/Warfarin) irrespective of INR
  12. Prior use (within 48 hours) of direct thrombin inhibitors (dabigatran) or direct factor Xa inhibitors (rivaroxaban, apixaban)
  13. Within prior 3 months: intracranial or spinal surgery, head trauma, or previous stroke
  14. Arterial puncture at non-compressible site within last 7 days
  15. Woman of child bearing age who has a positive pregnancy test
  16. NIH stroke scale >25 (severe deficit) or <4 and no dysphasia (mild deficit) or rapidly improving
  17. Symptoms spontaneously clearing
  18. 14 days post-operative or post major trauma
  19. Recent gastrointestinal or urinary tract hemorrhage within the past 21 days
  20. Recent acute MI within the past 3 months
  21. Serum glucose <50 mg/dl or >400 mg/dL
  22. Age >80 or less than 18
  23. History of ischemic stroke AND diabetes mellitus
  24. Unable to obtain consent from patient or power of attorney
  25. Baseline mRS > 2
  26. Consent not obtained by 20 minutes prior to closure of the therapeutic window.
  27. The subject has been treated with a thrombolytic agent within the past 72 hours
  28. The subject is a pregnant woman (positive serum βHCG pregnancy test, positive urine pregnancy test or clinically evident pregnancy)
  29. The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tenecteplase
Tenecteplase 0.25 mg/kg IV - Maximum dose: 25 mg
Drug: Tenecteplase
Tenecteplase 0.25 mg/kg IV - Maximum 25 mg
Other Names:
  • TNKase
Active Comparator: Alteplase
Alteplase 0.9 mg/kg IV - Maximum dose: 90 mg
Drug: Alteplase
Alteplase 0.9 mg/kg IV - Maximum: 90 mg
Other Names:
  • Activase
  • t-PA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological outcome
Time Frame: 90 days
Measured by modified Rankin Scale score
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic intracranial hemorrhage
Time Frame: 24 hours
Twenty-four hour brain CT scan showing intracranial hemorrhage in conjuction with neurological deterioration of 4 points or more on the NIHSS
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reza Behrouz, DO

Investigators

  • Principal Investigator: Reza Behrouz, DO, The Ohio State University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

June 21, 2014

First Submitted That Met QC Criteria

June 30, 2014

First Posted (Estimate)

July 2, 2014

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013H000
  • TALISMAN (Other Identifier: The Ohio State University College of Medicine)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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