February 1, 2023

Knowledge Translation Project Part 3

So the study were looking at today is titled clopidogrel and aspirins and acute ischemic stroke and high risk ti a it was published in march of 2018 and just as a bit of the background information to catch you guys off it was a double-blind randomized control trial that compared the rates of the scheming stroke in my death from ischemic vascular causes ischemic or

Hemorrhagic stroke at between patients taking aspirin alone or ana combination of vinegar and aspirin together so this was tested for the first three months after the initial event happened and the trial also compared the safety of the two regiments with the primary safety outcome so the population that was tested were patients 18 years of age and older originating

From 10 countries across north america europe australia and new zealand who had had me cute is eating stroke or a high risk t ia the intervention was the combination of clopidogrel and aspirin whereas the control was a placebo plus possibly the outcome that was studied was the risk of a composite of his eating stroke mi or death from is aiming faster cause from a

Safety perspective the risk of major hemorrhage was also evaluated and the results of this study showed that patients who receive a combination of clopidogrel and aspirin a screen five percent overall risk of a major ischemic event but this combination also put patients at an increased risk of a hemorrhage to discuss some of the critical appraisal strings that he

Found so one of the main strings for this paper in terms of study design was the largest sample size so just hundred five thousand patients were enrolled in the study and was pretty much split 50-50 for her patients put into that control group and each was put in the combination of aspirin and clopidogrel group a larger sample size such as this one will decrease

The risk of attrition bias and more accurately reflects the general population and decreases the chance that were ever been missed this study was a double blinded trial which would decrease both performance and detection biased and the researchers did not know what each patient received thus they would not treat anybody differently and the patients didn’t know when

They were receiving which decreases the chance that they would over report yes so in terms of randomization it was very well done this study used an interactive web-based system to randomize patients in a one-to-one ratio and there were no statistically significant differences in the baseline in their analysis after the trial is completed the researchers used in

Intention-to-treat analysis which preserves the randomization of gel mentions only six point four percent of participants in the combination group and six point eight in the aspirant only group were withdrew or lost to follow-up and this is pretty close to the 5% that states are still to me little biased and trial unfortunately there were also a few weaknesses for

Us to consider so 1.7 percent of the patients who are assigned to the control group were already taking control of their time of the presentation so in some of these patients as possible at the previous use of clopidogrel could have had an impact on a trial results and while the dose of clever girl was kept constant for all the participants the dose of aspirin vary

Between each patient decided by their treating physician and while we appreciate that each patient received personalized care we should question if the dose of aspirin have any impact on the risk of hemorrhage this study was also stopped early and this may be considered a weakness however the study seemed to be overpowered as it was stated that the treatment effect

Had crossed the significance boundary both for efficacy and risk of harm so now we’re just going to get into some of the current recommendations made in practice today according to the calgary stroke program the long-term use of a si+ clopidogrel is not routinely recommended for secondary prevention of ischemic events in patients with a history of stroke or tiaa

But it may be warranted in patients with other compelling indications such as recent mi but in the canadian heart and stroke foundation’s guidelines for secondary prevention of stroke from 2017 they found that short-term concurrent use of a si and clopidogrel after 21 days did not show an increased risk of bleeding and could be protective following a minor stroke

Or transient ischemic attack and in terms of the applicability to patient care most provinces have a stroke rate of about 800 patients per year whereas newfoundland has a rate of 1,200 to 1,400 per year and it’s the third highest cause of death in canada newfoundland has both the highest incidence of stroke and the poorest outcomes according to study results he

Never needed to treat was 67 for the intervention group and the number you to define was much larger at 200 we decided that this was a well-designed study and the results were valid so the results should be taken into consideration when treating patients but it’s also very important to focus on individual patients risk factors so if a patient is already at higher

Risk of hemorrhage you don’t use the combination therapy and only use the combination therapy for the first seven days because after that the risk of hemorrhage increases and the benefit also decreases

Transcribed from video
An Appraisal of "Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA" By Pharm 4620