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Grant: Project Grant

McMaster University

$336,600.00

Combination Antithrombotic Thrombotic therapy for prevention of recurrent Ischemic Stroke in patients with IntraCranial Atherosclerotic Disease (CATIS-ICAD)

EF 2021-22

Résumé
Stroke is the 3rd leading cause of death and primary cause of disability in Canada and globally. Stroke caused by narrowing of the brain arteries from cholesterol plaques is the commonest cause of stroke. Many patients with narrowing of brain arteries suffer "silent" strokes, that are only picked up by MRI scans of the brain, in addition to the diagnosed symptomatic stroke. "Silent" strokes are about four times common as symptomatic stroke and overtime lead to significant memory and gait difficulties. Currently when someone has a stroke due to narrowed arteries they are treated with aspirin, blood pressure and cholesterol-lowering medications to prevent another stroke. However even with these treatments, there is a high risk of recurrent stroke (1 in 20 chance in 30 days and 1 in 10 chance at one year) A recent study in patients with narrowing of arteries in heart and limbs that added low-dose rivaroxaban (blood thinner) to aspirin showed a 50% reduction of stroke without an increase in bleeding into the brain or fatal bleeding. We plan to assess if use of low-dose rivaroxaban and aspirin is safe (no increase bleeding into brain) in patients with stroke due to narrowing of brain arteries. The ultimate goal of this pilot study is to gather necessary information to plan for a larger study to assess for effectiveness of this combination in preventing recurrent symptomatic and "silent" strokes. If this combination is eventually confirmed to reduce stroke by 50%, it would be the biggest advance in secondary stroke prevention in the past 30 years. We will enrol 100 patients from 10 Canadian sites and randomly assign to the combination treatment (50) or aspirin (50). Patients will qualify to be in the study if they are over 40 years and has a stroke or transient ischemic attack (warning stroke) due to narrowing of the brain arteries by plaque. Patients will be followed for 2 years and have an MRI scan at the beginning and end of the study to look for "silent" strokes.
Programme
Project Grant
Bénéficiaire
Emplacement
Ontario, Canada
Type de bénéficiaire
Academia
Type
Grant
Source
CIHR Funding Decisions Database

Tel que publié

Id
444831
Name
Perera Kanjana S
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Circulatory and Respiratory Health
Theme2
Clinical
Prcname2
Randomized Controlled Trials 2
Projecttitle
Combination Antithrombotic Thrombotic therapy for prevention of recurrent Ischemic Stroke in patients with IntraCranial Atherosclerotic Disease (CATIS-ICAD)
Programtype2
Operating Grants
Orgnameinp2
McMaster University
Cihramount2
$336,600
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Combination Antithrombotic Therapy; Intracranial Atherosclerotic Disease; Ischemic Stroke; Low-Dose Rivaroxaban Plus Aspirin; Rivaroxaban; Stroke Secondary Prevention; Transient Ischemic Attack
Abstract
Stroke is the 3rd leading cause of death and primary cause of disability in Canada and globally. Stroke caused by narrowing of the brain arteries from cholesterol plaques is the commonest cause of stroke. Many patients with narrowing of brain arteries suffer "silent" strokes, that are only picked up by MRI scans of the brain, in addition to the diagnosed symptomatic stroke. "Silent" strokes are about four times common as symptomatic stroke and overtime lead to significant memory and gait difficulties. Currently when someone has a stroke due to narrowed arteries they are treated with aspirin, blood pressure and cholesterol-lowering medications to prevent another stroke. However even with these treatments, there is a high risk of recurrent stroke (1 in 20 chance in 30 days and 1 in 10 chance at one year) A recent study in patients with narrowing of arteries in heart and limbs that added low-dose rivaroxaban (blood thinner) to aspirin showed a 50% reduction of stroke without an increase in bleeding into the brain or fatal bleeding. We plan to assess if use of low-dose rivaroxaban and aspirin is safe (no increase bleeding into brain) in patients with stroke due to narrowing of brain arteries. The ultimate goal of this pilot study is to gather necessary information to plan for a larger study to assess for effectiveness of this combination in preventing recurrent symptomatic and "silent" strokes. If this combination is eventually confirmed to reduce stroke by 50%, it would be the biggest advance in secondary stroke prevention in the past 30 years. We will enrol 100 patients from 10 Canadian sites and randomly assign to the combination treatment (50) or aspirin (50). Patients will qualify to be in the study if they are over 40 years and has a stroke or transient ischemic attack (warning stroke) due to narrowing of the brain arteries by plaque. Patients will be followed for 2 years and have an MRI scan at the beginning and end of the study to look for "silent" strokes.
Competitiondate
202104
Approvedterm2
2 yrs 4 mths
Pinamesdelim
Perera, Kanjana S
Approvedterm
2 ans 4 mois
Cihrcontribution2
~ $336,600~ $0~