This RCT seeks to appraise the study “Addition of clopidogrel to aspirin in 45. 852 patients with acute myocardial infarction: randomized placebo-controlled trial”. This is for the simple reason that in the recent past, numerous modalities have been used for the treatment of myocardial infarction (MI) and others are still in the pipeline being established. Looking at the background, platelet activation and aggregation can be treated using thromboxane; these two rise during myocardial infarction. Aspirin has proved to be effective in reduction of mortality while Clopidogrel has proven effective enough to deal with ischemic events (Docherty, 2011).
Clinical question and PICOT related to the problem
IN PATIENTS WITH MYOCARDIAL INFARCTION IS ASPIRIN BENEFICIAL WHEN USED ALONE OR IN ADDITION TO CLOPIDOGREL?
P- Patients with Myocardial infarction
I- Aspirin
C- Clopidogrel plus Aspirin
O- Reduction or prevention of myocardial infarction events
T- 28 days
Keywords used and the database system
Headings and words used were closely related to clopidogrel and aspirin, myocardial infarction, mortality, major morbidity, stroke and study type (i.e., “randomized controlled trial”). All were searched in databases like Cochrane library and MEDLINE (White, 2008).
Appraisal: In critically appraising this article, the following factors were assessed and how the article addresses them.
– Valid clinical problem and clinical question: While discussing the validity of the problem and to what extent this article solves the matter at hand, we see that the study sticks to its objective and delivers desirable results.
– Validity of the results: The article that they pursues a 2 by 2 factorial design and randomization was used in allocation of clopidogrel 75 mg daily (n=22 961) or matching placebo (n=22 891) in addition to aspirin 162 mg daily. There was also use of sealed study treatments (Nursing, 2007).The study has also shed some light in measuring the study’s outcome and performance, in doing so, the study ensured that there was a 4 week calendar that was followed to the letter except in arising medical situations. As stated in the study that unless a definite contraindication arose then medication would continue as planned hence outcome measures.
The study also does a follow-up: this is done through a form which is filled and contains details on compliance, effects of the therapy either positive or negative, clinical events, death if it occurred. Also noticeable is that the study did not conduct any post-discharge follow-up. Hence, this study falls deficient in that regard and has failed to address sufficiently the complete follow-up which is vital to any patient’s recovery.
– The results: In the analysis of the results of this study, we exploit such factors as the statistical methods used. Our objective is to compare the group mean value on the continuous outcome variable between or among the group as done below.
Primary outcome: Clopidogrel Mean = 654.33; Standard Deviation = 886.4
Placebo: Mean = 707.67; Standard Deviation = 811.36
Secondary outcome: Clopidogrel Mean = 201.38; Standard Deviation = 87.34
Placebo: Mean = 232; Standard Deviation = 155.35
Secondly, we will look at statistical significance: the P value is 0.002 which is less than 0.05, meaning it is highly significant (DiCenso, 2009).
Clinical Meaningfulness is also vital in the analysis of results. The NNT is not available in the study leaving the study lacking in trying to estimate the clinical meaning of the therapy.
Application of results to patients care
In trying to establish the provider’s perspective, the study does a good job in examining all the clinically important outcomes when it evaluates the primary outcome death, reinfarction, and stroke. The study goes ahead to assess the efficacy of the outcomes.
When looking at the application of the study, we note that using clopidogrel in acute MI requires less monitoring. The low cost of this modality is also recommendable thus the medication can be used in populations where medical resources are limited.
The study also reveals that in using clopidogrel, time frame is not important since it does not require close and careful monitoring (Brandon, 2011).As a Nurse Practitioner I will like to consider a dual therapy wit aspirin and clopidogrel over a single therapy with aspirin , for the benefit of my patients.
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