Article Text
Abstract
Introduction Since the five major randomized controlled trials (RCTs) that revolutionized acute ischemic stroke (AIS) treatment through mechanical thrombectomy in 2015, there is an increase in clinical studies evaluating a variety of treatments and techniques.
Aim of Study This systematic review evaluates AIS clinical studies to understand global trends.
Methods Registered clinical studies on AIS were systematically reviewed on Clinicaltrials.gov until Dec 2023. Studies were categorized as diagnostic, treatment, management, or workflow. For each study, extracted variables included device or drug class and name, study status, randomization, start and end years. Studies were grouped into 4-year periods based on start date: Y1 (2000-2003), Y2 (2004-2007), Y3 (2008-2011), Y4 (2012-2015), Y5 (2016-2019), and Y6 (2020-2023). A Pearson’s chi-squared test for association was performed comparing categories to study status, randomization, and periods.
Results Out of 1374 records screened, 1105 were included, categorized as management (n=540), treatment (n=309), diagnosis (n=214), and workflow (n=41). Initiated studies have nearly doubled every period from Y1 (n=31) to Y6 (n=455). Primary interventions were devices (n=215) or drugs (n=514) with cerebro-protective (n=225) and thrombolytics (n=106) being the most common. Chi-squared tests revealed management studies most likely to be randomized while diagnostic studies the least (p<0.001); treatment studies were stopped (withdrawn, terminated, or suspended) more than expected while all others were the opposite (p<0.001); treatment studies were observed more than expected in final period (Y6, 2020 to 2023) while diagnostic studies observed less than expected (p=0.01).
Conclusion Registered clinical studies on AIS have been increasing exponentially, particularly those investigating cerebro-protective drugs and reperfusion devices.
Disclosure of Interest no.