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Grant: Project Grant

University of Calgary

$1,277,550.00

Alteplase Compared to Tenecteplase in patients with Acute Ischemic Stroke: QuICR & OPTIMISE Registry based Pragmatic Randomized Controlled Trial

EF 2018-19

Résumé
When a clot blocks blood supply to a blood vessel supplying the brain, it causes a stroke. Patients who suffer from stroke can lose important brain functions like speech, motor power and vision can even die from the stroke. Modern acute stroke treatment is based on removing the clot from the blocked artery either by dissolving the clot using a clot busting drug (alteplase) or by removing the clot mechanically. The clot busting drug (alteplase) that is currently being used does not always succeed in dissolving the clot. Small recent studies show that newer drugs like tenecteplase may have better ability to dissolve clots blocking brain arteries while also being safer than alteplase when used in patients with acute stroke. Moreover, tenecteplase is a single injection unlike alteplase which is given using an infusion pump over a period of an hour. This means tenecteplase could be given more easily, thus saving time. Time saved is brain saved. Tenecteplase may also result in less need for expensive stroke therapies such as mechanical removal of clots, thus saving costs. We therefore propose a randomized trial that compares intravenous tenecteplase to intravenous alteplase in patients who are currently being treated with intravenous alteplase. The trial will enroll 1600 patients from 25 emergency departments across Canada. The trial will use a pragmatic design so as to not affect patient care in any way. Patients and caregivers will be engaged to inform study design and conduct. All data for the trial will be collected from ongoing patient registries, thereby reducing the costs of running such a trial significantly. The results of this trial are likely to change clinical practice, improve delivery of care to acute stroke patients, result in better patient outcomes and save the health system costs.
Programme
Project Grant
Bénéficiaire
Emplacement
Alberta, Canada
Type de bénéficiaire
Academia
Type
Grant
Source
CIHR Funding Decisions Database

Tel que publié

Id
401715
Name
Menon Bijoy K
Region
Alberta
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Circulatory and Respiratory Health
Theme2
Clinical
Prcname2
Randomized Controlled Trials 2
Projecttitle
Alteplase Compared to Tenecteplase in patients with Acute Ischemic Stroke: QuICR & OPTIMISE Registry based Pragmatic Randomized Controlled Trial
Programtype2
Operating Grants
Orgnameinp2
University of Calgary
Cihramount2
$1,277,550
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Acute Ischemic Stroke; Intravenous Thrombolysis; Pragmatic; Randomized Controlled Trial; Registry
Abstract
When a clot blocks blood supply to a blood vessel supplying the brain, it causes a stroke. Patients who suffer from stroke can lose important brain functions like speech, motor power and vision can even die from the stroke. Modern acute stroke treatment is based on removing the clot from the blocked artery either by dissolving the clot using a clot busting drug (alteplase) or by removing the clot mechanically. The clot busting drug (alteplase) that is currently being used does not always succeed in dissolving the clot. Small recent studies show that newer drugs like tenecteplase may have better ability to dissolve clots blocking brain arteries while also being safer than alteplase when used in patients with acute stroke. Moreover, tenecteplase is a single injection unlike alteplase which is given using an infusion pump over a period of an hour. This means tenecteplase could be given more easily, thus saving time. Time saved is brain saved. Tenecteplase may also result in less need for expensive stroke therapies such as mechanical removal of clots, thus saving costs. We therefore propose a randomized trial that compares intravenous tenecteplase to intravenous alteplase in patients who are currently being treated with intravenous alteplase. The trial will enroll 1600 patients from 25 emergency departments across Canada. The trial will use a pragmatic design so as to not affect patient care in any way. Patients and caregivers will be engaged to inform study design and conduct. All data for the trial will be collected from ongoing patient registries, thereby reducing the costs of running such a trial significantly. The results of this trial are likely to change clinical practice, improve delivery of care to acute stroke patients, result in better patient outcomes and save the health system costs.
Competitiondate
201903
Approvedterm2
3 yrs 0 mth
Pinamesdelim
Menon, Bijoy K; Buck, Brian H; Goyal, Mayank; Hill, Michael D; Swartz, Richard
Approvedterm
3 ans 0 mois
Cihrcontribution2
~ $1,277,550~ $0~