Study Type
Interventional - Drug
ongoing
CATIS-ICAD is the first pilot RCT assessing safety of low-dose rivaroxaban plus ASA in patients with recent ischemic stroke/high-risk TIA secondary to intracranial atherosclerotic disease (ICAD), an area where a huge interest exists within the stroke community.
Primary endpoints:
Demonstrating comparable safety to antiplatelet therapy is likely to have far reaching clinical impact, as this combination therapy then potentially could be used for patients with both intracranial and extracranial atherosclerotic disease. (The COMPASS trial already established that it is safe and effective in stroke prevention in extracranial atherosclerotic disease.)
Demonstration of safety and a trend towards efficacy in rivaroxaban plus ASA arm when compared with the ASA arm will provide a platform for a phase III efficacy trial.
CATIS-ICAD Protocol - Download PDFStudy Design
Randomized, open-label, blinded endpoint, pilot trial
NO. of Countries
1
NO. of Sites
10
NO. of Participants
115
Study Period
2020-2023
Sponsor
PHRI
Robert Hart
Senior Scientist
Robert Hart
Senior Scientist
Robert Hart is Professor of Medicine (Neurology) at McMaster University and a vascular neurologist at Hamilton Health Sciences. After completing a fellowship in cerebrovascular disease at the Oregon Health Sciences University, he spent most of his career at the University of Texas Health Science Center in San Antonio before relocating to McMaster University in September 2011.
He has a long-standing interest in stroke, stroke research, and clinical trials. He has directed several randomized clinical trials serving as the principal investigator of the NIH/NINDS-sponsored Stroke Prevention in Atrial Fibrillation (SPAF) I, II and III trials (1987-2000) and co-principal investigator of the NIH/NINDS-sponsored Secondary Prevention of Small Subcortical Strokes (SPS3) randomized trials (2001-2013). Antithrombotic therapies to prevent stroke in atrial fibrillation and especially novel oral anticoagulants are areas of special interest. He has published more than 250 articles in peer-reviewed journals.
Kanjana Perera
Scientist
Kanjana Perera
Scientist
Kanjana (Sashi) Perera is a Scientist in the Brain Health and Stroke research program at PHRI, Assistant Professor, Medicine (neurology), McMaster University, and a stroke neurologist at Hamilton Health Sciences. Her main research focus is on secondary stroke prevention, cryptogenic stroke, and uncommon causes of stroke and the optimization of clinical care in this patient population.
She has served as Principal Investigator and Co-Investigator for Phase II and III clinical trials, and is on the adjudication committees for international multicenter stroke/cardiovascular trials. She has won research awards, and her work has been published in high-impact medical journals. She obtained her medical degree from Sri Lanka with Honors for academic excellence. She completed her training in Neurology at the University of Western Ontario in 2013 and subsequently pursued a fellowship in Stroke/Vascular Neurology at McMaster University.
Danielle de Sa Boasquevisque
Associate Research Fellow
Danielle de Sa Boasquevisque
Associate Research Fellow
Danielle de Sa Boasquevisque is an Associate Research Fellow at PHRI, supervised by Ashkan Shoamanesh, and is pursuing a Masters in Health Research Methodology at McMaster University. At PHRI, she is a co-Investigator in the ENRICH-AF trial and Project Officer for the CATIS-ICAD trial.
She obtained her MD from Federal University of Espirito Santo in Brazil and has completed internal medicine and neurology training in Sao Paulo, Brazil. In 2018, she completed her MSc in Neuroscience at Albert Einstein Institute/Sao Paulo, Brazil where she studied safety of transcranial direct current stimulation in patients after ischemic stroke. She also pursued a two-year clinical Stroke fellowship at McMaster University from 2018 to 2020.
Danielle has research interests in vascular neurology including acute stroke, neuro-rehabilitation, intracranial atherosclerotic disease and intracerebral hemorrhage. She is currently implementing an ICH cohort study and performing systematic review regarding ICH related outcomes.
Amanda Taylor
Associate Program Manager
Amanda Taylor
Associate Program Manager
Amanda Taylor is an Associate Program Manager who currently coordinates trials in stroke, and has experience conducting trials in acute coronary syndrome and arrhythmia. Amanda joined PHRI in 2007. She holds a Bachelor of Science Degree (Honours) in Neurobiology from Brock University.
