Tenecteplase Versus Alteplase in Ischemic Stroke Management (TALISMAN)

Phase

2/3

Condition

Stroke

Cerebral Ischemia

Thrombosis

Treatment

N/A

Clinical Study ID

NCT02180204

2013H000

TALISMAN

Ages 18-80
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

January 01, 2015

June 30, 2020

Study 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.

Connect with a study center

The Ohio State University College of Medicine
Columbus, Ohio 43210
United States
Site Not Available

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