CURRENT RECRUITING TRIALS
For more information:
info-CRU.neuro@mcgill.ca
CAN-Point Prevalance Study (ICU)
Intensive are units (ICUs) provide minute by minute monitoring, life support interventions like mechanical ventilation, and potent medications designed to support a person through catastrophic,
life-threatening illnesses. However, these interventions are resource intensive and they carry considerable risks.
In this complex and unique setting, it is imperative that the care provided in ICUs beguided by trustworthy scientific evidence, and that the process whereby science informs care be able to evolve through continuous learning, innovation, and improvement.
This project will shed light on what separates us from realizing a learning critical care health system in Canada. Specifically, it will strengthen our understanding of who is admitted to Canadian ICUs, which interventions they receive, and where research may be embedded into care. The ultimate objective of a learning critical care health system is to generate new knowledge and implement it into practice efficiently and rapidly.
CHUM - TOBAS
Treatment of Brain Arteriovenous Malformations (AVM)
The objectives of this study and registry are to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty. Management may include interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination) or conservative management.
The trial has been designed to test a) whether medical management or interventional therapy will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and, b) to test if endovascular treatment can improve the safety and efficacy of surgery or radiation therapy by at least 10% (80% to 90%).
CHUM EASI-TOC
ENDOVASCULAR ACUTE STROKE INTERVENTION TANDEM OCCLUSION STUDY (EASI_TOC)
A trial of acute cervical internal carotid artery stenting during endovascular thrombectomy for anterior circulation stroke.Â
Patients with tandem occlusion or tandem lesion (TL), that is, stroke with an acute intracranial anterior circulation occlusion and an ipsilateral cervical ICA (c-ICA) high-grade stenosis or occlusion, constitute about 15-20% of patients undergoing endovascular thrombectomy (EVT).
However, the optimal treatment of acute stroke patients with TL remains uncertain, as relatively few patients with TL were included in the major randomized controlled trials of EVT and management of the c-ICA was generally not specified by protocol nor analyzed post-hoc.
Recent large multi-centre retrospective cases series suggest that acutely stented patients may have more favorable outcomes than patients treated with angioplasty alone or those with no acute ICA intervention, but high quality randomized trial data are lacking.
EASI-TOC, a phase 3, academic multi-centre, controlled trial (PROBE design) with embedded pilot phase, will seek to determine if in patients undergoing acute intracranial thrombectomy for anterior circulation stroke with concurrent ipsilateral symptomatic high-grade (≥70%) atherosclerotic stenosis or occlusion of the extracranial ICA, endovascular ICA revascularization with stenting is superior to intracranial thrombectomy alone with regards to functional outcome at 90 days. Patients will be randomized to Acute stenting or No acute stenting (1:1 allocation).
The Team
Dr Aimen Moussady
Principal Investigator
Dr Maria Cortes Niño
Principal Investigator
The Team
Dr C. Legault
Principal Investigator
Rick Sanchez
Clinical Research Coordinator
UPCOMING TRIALS
OPTIMISE
To support the optimal provision of endovascular therapy (EVT)for the treatment of acute ischemic stroke by providing a quality assurance initiative to Canadian institutions that offer this therapy.
ACTIVE (NOT RECRUITING) TRIALS
Bayer OCEANIC-STROKE
Phase 3 study to investigate the efficacy and safety of the oral FXIa inhibitor Asundexian (BAY 2433334) compared with placebo in participants after an acute non-cardioembolic ischemic stroke or high-risk TIAÂ
Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had:
- an acute stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or
- TIA/mini-stroke with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Acute ischemic strokes or TIA/mini-stroke result from a blocked or reduced blood flow to a part of the brain. They are caused by blood clots that travel to the brain and block the vessels that supply it. If these blood clots form elsewhere than in the heart, the stroke is called non-cardioembolic. People who already had a non-cardioembolic stroke are more likely to have another stroke. This is why they are treated preventively with an antiplatelet therapy, the current standard of care. Antiplatelet medicines prevent platelets, components of blood clotting, from clumping together.
Anticoagulants are another type of medicine that prevents blood clots from forming by interfering with a process known as coagulation (or blood clotting).
The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care without increasing the risk of bleeding.
The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or TIA/mini-stroke when given in addition to standard antiplatelet therapy. A placebo is a treatment that looks like a medicine but does not have any medicine in it.
Another aim is to compare the occurrence of major bleeding events during the study between the asundexian and the placebo group. Major bleedings have a serious or even life-threatening impact on a person’s health.
Dependent on the treatment group, the participants will either take asundexian or placebo as tablets once a day for at least 3 months up to 31 months.
Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. In addition, one visit before and up to two visits after the treatment period are planned.
PHRI ENRICH-AF
EdoxabaN for IntraCranial Hemorrhage Survivors with Atrial Fibrillation (ENRICH-AF)
To assess whether edoxaban (60/30 mg daily) compared to non-antithrombotic medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke (composite of ischemic, hemorrhagic and unspecified stroke) or systemic embolism in high-risk atrial fibrillation (CHA2DS2-VASc ≥2) patients with previous intracranial hemorrhage.