The open-label design had the potential to introduce bias; however, all the events for which medical attention was sought were adjudicated by the members of an independent committee who were unaware of trial-group assignments. 2020 Aug;34(4):555-568. doi: 10.1007/s10557-020-06981-3.Cainzos-Achirica M, Miedema MD, McEvoy JW, Al Rifai M, Greenland P, Dardari Z, Budoff M, Blumenthal RS, Yeboah J, Duprez DA, Mortensen MB, Dzaye O, Hong J, Nasir K, Blaha MJ.Circulation. Moayyedi P(1), Eikelboom JW(2), Bosch J(2), Connolly SJ(2), Dyal L(3), Shestakovska O(2), Leong D(2), Anand SS(2), Störk S(4), … Please enable it to take advantage of the complete set of features! When patients stop smoking, better control their lipids and blood pressure, and adopt healthier lifestyles, their future risk is lowered. We used a one-sided alpha level of 0.025 to analyze the noninferiority of rivaroxaban monotherapy, as compared with combination therapy, with a noninferiority margin of 1.46.If noninferiority was shown for the primary efficacy end point, a closed testing procedure was to be conducted to determine superiority for the primary safety end point. It could be argued that cardiovascular and bleeding events are not equivalent, but mortality associated with bleeding is substantial, and haemorrhagic strokes are on average more disabling (and more likely to be fatal) than ischaemic strokes.The ASCEND population was at lower cardiovascular risk than had been anticipated when the trial was designed.
Epub 2019 Nov 5.Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dyal L, Shestakovska O, Leong D, Anand SS, Störk S, Branch KRH, Bhatt DL, Verhamme PB, O'Donnell M, Maggioni AP, Lonn EM, Piegas LS, Ertl G, Keltai M, Bruns NC, Muehlhofer E, Dagenais GR, Kim JH, Hori M, Steg PG, Hart RG, Diaz R, Alings M, Widimsky P, Avezum A, Probstfield J, Zhu J, Liang Y, Lopez-Jaramillo P, Kakkar AK, Parkhomenko AN, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Vinereanu D, Tonkin AM, Lewis BS, Felix C, Yusoff K, Metsarinne KP, Fox KAA, Yusuf S; COMPASS Investigators.Gastroenterology. The study … The trial database was locked in January 2019. The calculation of the trial sample size is provided in the The primary efficacy analysis was based on the modified intention-to-treat approach.
Clearly, clinical equipoise remains possible; despite the perception as a relative contraindication, antithrombotic therapy resumption is now reported in … Further, it is likely more motivating for patients to take a medication long term when they already have disease and are concerned about preventing the next event. However, because of a higher risk of death from any cause in the combination-therapy group, the independent data and safety monitoring committee recommended early termination of the trial in July 2018. The trial met its primary objective of showing the noninferiority of rivaroxaban monotherapy, as compared with combination therapy with rivaroxaban plus antiplatelet therapy, for the composite of cardiovascular events or death from any cause.
The primary objective of this trial is to assess the effects of ticagrelor plus aspirin versus clopidogrel plus aspirin on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in CYP2Y19 … The primary endpoint was a composite of all-cause death, dementia, or physical disability. 1 This proportional reduction translated into an annual absolute reduction of 1.5% (i.e., 15 fewer events for every 1,000 patients treated for 1 year).
Epub 2019 Nov 5.Gastroenterology. This led to some adaptations to the design (increase in sample size and duration and addition of TIA to the definition of serious vascular events) by the steering committee (while remaining blind to the effects of treatment), which improved the statistical sensitivity of the trial.As shown in Figure 2, the risk of vascular events (e.g., myocardial infarction, stroke, and cardiovascular death) in secondary prevention populations has significantly fallen since the trials that first demonstrated the benefits of aspirin in these populations (due to secular trends and other effective therapies such as lowering low-density lipoprotein cholesterol with statins and improved blood pressure control). 2020 Jan;158(1):283-284. doi: 10.1053/j.gastro.2019.08.063.