Protocol for systematic review and meta-analysis on randomized clinical trials for direct oral anticoagulant in subjects with acute coronary syndrome

Background: Recently, direct oral anticoagulant (DOAC) has been projected for secondary prevention of recurrent ischemic events post-acute coronary syndrome (ACS). The addition of a DOAC to the antiplatelet regimen of subjects with the ACS is clinically practiced in candidates where compelling anticoagulation is indicated by high thromboembolic risk. The current evidence provides approved compelling indication for the DOAC, particularly for rivaroxaban which bears the strongest existing evidence. Objective: We intend to assess the role of DOAC in addition to single or dual antiplatelet therapy in subjects with ACS. We will compare the clinical characteristics and explore the efficacy and safety of the DOAC class members (apixaban, betrixaban, dabigatran, edoxaban and rivaroxaban) in terms of reduction in ischemic events in subjects with ACS (ST-segment elevation myocardial infarction [STEMI] or non–ST-segment elevation [NSTEMI]) or subjects who underwent percutaneous coronary intervention (PCI) and or ACS and coexisting atrial fibrillation (AF). Methods: Relevant data will be searched on known data-bases such as Embase, Google Scholar, the Cochrane Central, and PubMed. The trials included will be randomized controlled trials from 2009 to 2022. Subjects will be receiving DOAC for ACS were evaluated for inclusion. The extraction, synthesis, quality, and validity of data will follow the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The risk of bias tool, version 2.0 (Cochrane) will be used for risk of bias assessment. Data will be pooled using random-effects models. The primary outcome measure will be efficacy end point (composite of cardiovascular death, myocardial infarction, and stroke), while the safety outcome will be minor/major bleeding. (AU)

Double blind randomized controlled trial for subjects undergoing surgery receiving surgical antimicrobial prophylaxis at tertiary hospital: the clinical pharmacist’s interventions

Background: A surgical site infection (SSI) has significant clinical, humanistic and economic consequences. Surgical antimicrobials prophylaxis (SAP) is a reliable standard to prevent SSIs. Objective: The objective was to test that the clinical pharmacist’s interventions may facilitate the implementation of SAP protocol and subsequent reduction of SSIs. Methods: This was double blinded randomized controlled interventional hospital-based-study at Khartoum State-Sudan. A total of 226 subjects underwent general surgeries at four surgical units. Subjects were randomized to interventions and controls in a (1:1) ratio where patient, assessors and physician were blinded. The surgical team has received structured educational and behavioral SAP protocol mini courses by way of directed lecturers, workshops, seminars and awareness campaigns delivered by the clinical pharmacist. The clinical pharmacist provided SAP protocol to the interventions group. The outcome measure was the primary reduction in SSIs. Results: There were (51.8%, 117/226) females, (61/113 interventions versus 56/113 controls), and (48.2%, 109/226) males (52 interventions and 57 controls). The overall rate of SSIs was assessed during 14 days post-operatively and was documented in (35.4%, 80/226). The difference in adherence to locally developed SAP protocol regarding the recommended antimicrobial was significant (P <0.001) between the interventions group (78, 69%) and the controls group (59, 52.2%). The clinical pharmacist’s implementation of the SAP protocol revealed significant differences in SSIs with reduction in SSIs from 42.5% to 25.7% versus the controls group from 57.5% to 44.2% respectively, P = 0.001 between the interventions group and the controls group respectively. Conclusion: The clinical pharmacist’s interventions were very effective in sustainable adherence to SAP protocol and subsequent reduction in SSIs within the interventions group. (AU)

Double blind randomized controlled trial for subjects undergoing surgery receiving surgical antimicrobial prophylaxis at tertiary hospital: the clinical pharmacist's interventions.

Background: A surgical site infection (SSI) has significant clinical, humanistic and economic consequences. Surgical antimicrobials prophylaxis (SAP) is a reliable standard to prevent SSIs. Objective: The objective was to test that the clinical pharmacist's interventions may facilitate the implementation of SAP protocol and subsequent reduction of SSIs. Methods: This was double blinded randomized controlled interventional hospital-based-study at Khartoum State-Sudan. A total of 226 subjects underwent general surgeries at four surgical units. Subjects were randomized to interventions and controls in a (1:1) ratio where patient, assessors and physician were blinded. The surgical team has received structured educational and behavioral SAP protocol mini courses by way of directed lecturers, workshops, seminars and awareness campaigns delivered by the clinical pharmacist. The clinical pharmacist provided SAP protocol to the interventions group. The outcome measure was the primary reduction in SSIs. Results: There were (51.8%, 117/226) females, (61/113 interventions versus 56/113 controls), and (48.2%, 109/226) males (52 interventions and 57 controls). The overall rate of SSIs was assessed during 14 days post-operatively and was documented in (35.4%, 80/226). The difference in adherence to locally developed SAP protocol regarding the recommended antimicrobial was significant (P <0.001) between the interventions group (78, 69%) and the controls group (59, 52.2%). The clinical pharmacist's implementation of the SAP protocol revealed significant differences in SSIs with reduction in SSIs from 42.5% to 25.7% versus the controls group from 57.5% to 44.2% respectively, P = 0.001 between the interventions group and the controls group respectively. Conclusion: The clinical pharmacist's interventions were very effective in sustainable adherence to SAP protocol and subsequent reduction in SSIs within the interventions group.