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Grant: Operating Grant: Clinical Trials Projects

University of Calgary

$4,048,545.00

A Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single-dose Design to Determine the Efficacy and Safety of NoNO-42 in Participants with Acute Ischemic Stroke Selected for Thrombolysis

EF 2023-24

Résumé
ACT-42 is a clinical study designed to improve the treatment of the most common form of stroke, namely, acute ischemic stroke. Acute ischemic stroke is a serious, time-sensitive, medical condition caused by sudden blockage of a brain artery. This leads to decreased blood flow to a region of the brain. With lack of blood flow, brain damage occurs rapidly. For this reason, restoring blood flow rapidly can be lifesaving. Blood flow can be restored using a clot busting medication (thrombolysis) and/or removal of clot using catheters (endovascular thrombectomy or EVT). However, despite the existence of these treatments, re-opening of the arteries may not be fast enough. This leaves many patients disabled. NoNO-42 is a medication developed by a Canadian biotechnology company. It is designed to protect brain cells when they are not getting enough nourishing blood, slowing brain damage and providing more time for thrombolysis or EVT. We will evaluate NoNO-42, comparing it to standard treatment, in patients who are treated with thrombolysis and/or EVT. In this study, both men and women who are between 45 to 90 years of age and suffering from acute ischemic stroke will be included. They will have a 50-50 chance to receive either the new medication, NoNO-42, or a placebo (a harmless substance with no real effect) along with the standard therapy. We will follow the participants for 90 days to see how well they recover from their stroke. The study will be conducted at several hospitals in Canada. A positive result showing that patients who received NoNO-42 will be a major global advance in the treatment of acute ischemic stroke.
Programme
Operating Grant: Clinical Trials Projects
Bénéficiaire
Emplacement
Alberta, Canada
Type de bénéficiaire
Academia
Type
Grant
Source
CIHR Funding Decisions Database

Tel que publié

Id
497188
Name
Menon Bijoy K
Region
Alberta
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Circulatory and Respiratory Health
Theme2
Clinical
Prcname2
Clinical Trials Projects - Full Application
Projecttitle
A Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single-dose Design to Determine the Efficacy and Safety of NoNO-42 in Participants with Acute Ischemic Stroke Selected for Thrombolysis
Programtype2
Operating Grants
Orgnameinp2
University of Calgary
Cihramount2
$4,048,545
Cihrequipment2
$0
Programname2
Operating Grant: Clinical Trials Projects
Keyworddelim
Acute; Neuro-Protection; Stroke; Thrombolysis
Abstract
ACT-42 is a clinical study designed to improve the treatment of the most common form of stroke, namely, acute ischemic stroke. Acute ischemic stroke is a serious, time-sensitive, medical condition caused by sudden blockage of a brain artery. This leads to decreased blood flow to a region of the brain. With lack of blood flow, brain damage occurs rapidly. For this reason, restoring blood flow rapidly can be lifesaving. Blood flow can be restored using a clot busting medication (thrombolysis) and/or removal of clot using catheters (endovascular thrombectomy or EVT). However, despite the existence of these treatments, re-opening of the arteries may not be fast enough. This leaves many patients disabled. NoNO-42 is a medication developed by a Canadian biotechnology company. It is designed to protect brain cells when they are not getting enough nourishing blood, slowing brain damage and providing more time for thrombolysis or EVT. We will evaluate NoNO-42, comparing it to standard treatment, in patients who are treated with thrombolysis and/or EVT. In this study, both men and women who are between 45 to 90 years of age and suffering from acute ischemic stroke will be included. They will have a 50-50 chance to receive either the new medication, NoNO-42, or a placebo (a harmless substance with no real effect) along with the standard therapy. We will follow the participants for 90 days to see how well they recover from their stroke. The study will be conducted at several hospitals in Canada. A positive result showing that patients who received NoNO-42 will be a major global advance in the treatment of acute ischemic stroke.
Competitiondate
202311
Approvedterm2
3 yrs 0 mth
Pinamesdelim
Menon, Bijoy K; Christenson, James M; Hill, Michael D; Singh, Nishita; Swartz, Richard; Tymianski, Michael
Approvedterm
3 ans 0 mois
Cihrcontribution2
~ $4,048,545~ $0~