Tenecteplase Versus Alteplase in Ischemic Stroke Management (TALISMAN)

Withdrawn before enrolling · Phase 2/Phase 3

Conditions studied: Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT02180204

Run by

Reza Behrouz, DO

People needed

0

Starts

2015-01-01

Expected to finish

2020-06-01

Last updated by the study team

2015-09-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 defined between 3 and 4.5 hours
• Treatment can be initiated within 3 to 4.5 hours from symptom onset

You may not qualify if…

• 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 >110 mmHg 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 direct factor 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 rapidly improving
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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