Phase 2
N=50
TNK-tPA Evaluation for Minor Ischemic Stroke With Proven Occlusion
Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01654445 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Patients With Serious Bleeding Events — 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tenecteplase (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Calgary
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Serious Bleeding Events |
0; 1 | — |
| SECONDARY Number of Patients With NIHSS 0 and mRS 0 and Barthel Index > 90 |
15; 19; 10; 14; 22; 22 | — |
Summary
This trial will enroll patients that have been diagnosed with a transient ischemic attack (TIA) or minor stroke that has occurred within the past 12 hours. Anyone diagnosed with a minor stroke faces the possibility of long-term disability and even death, regardless of treatment. Stroke symptoms such as weakness, difficulty speaking and paralysis may improve or worsen over the hours or days immediately following a stroke. The purpose of this research trial is to study the effects of a clot-dissolving drug, tenecteplase (TNK-tPA), as a treatment for patients who arrive within twelve hours from stroke onset. This study is attempting to see if TNK-tPA given through a vein in the arm (intravenous) to patients is a safe treatment for stroke patients. Neither the safety nor the effectiveness of this treatment has been proven yet.
This trial will be conducted at several site in Canada.
Dr Michael Hill and Dr. Shelagh Coutts are the Principal Investigators of this trial, coordinated at the University of Calgary, Foothills Medical Centre.
Eligibility Criteria
Inclusion Criteria
- Acute ischemic stroke in an adult patient (18 years of age or older)
- Onset (last-seen-well) time to treatment time 1/3 MCA territory or ASPECTS 12 hours of age.
- Clinical history, past imaging and clinical judgment suggest that the intracranial occlusion is chronic.
- Patient is a candidate for and should receive standard of care IV tPA.
- Stroke occurring as an in-patient. An in-patient is a person who has been officially admitted to the hospital to a ward bed. A patient in the ED who has not been formally admitted is still considered to be an outpatient.
- Patient has a severe or fatal or disabling illness that will prevent improvement or follow-up or such that the treatment would not likely benefit the patient.
- Patient cannot complete follow-up due to co-morbid non-fatal illness or is visiting the host sites city and cannot return for follow-up.
- Pregnancy.
- Patient is actively taking dual antiplatelet medication (aspirin & clopidogrel) in the last 48 hours.
- International normalized ratio > 1.4
- Standard thrombolysis exclusions (Taken from Canadian guidelines1)
NOTES: NIHSS = National Institutes of Health Stroke Scale ACA = anterior cerebral artery MCA = middle cerebral artery ICA = internal cerebral artery PCA = posterior cerebral artery VB = vertebrobasilar TICI = thrombolysis in cerebral ischemic scale CT = computed tomography NCCT = non-contrast CT CTA = CT angiography ASPECTS = Alberta Stroke Program Early CT Score IV = intravenous tPA = tissue plasminogen activator ED = Emergency Department
Data sourced from ClinicalTrials.gov (NCT01654445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.