BACKGROUND. Prasugrel and Ticagrelor are superior to Clopidogrel in ST-segment elevation myocardial infarction (STEMI) patients to reduce ischemic events. Patients with diabetes mellitus (DM) have increased platelet reactivity (PR) with a reduced response to antiplatelet agents in particular those on insulin treatment.
METHODS. We will perform a randomized trial to compare the PR following loading dose (LD) of Prasugrel and Ticagrelor in STEMI patients with DM and naïve for platelet P2Y12 receptor inhibitors. The PR assessments will be performed before LD administration and after 1-2-6-12 hours. The primary end-point is the superiority antiplatelet effect of Prasugrel vs Ticagrelor at 2 hours. Secondary end-points are PR measured at 1-6-12 hours. Finally a subanalysis will be performed between two study groups according to insulin treatment.
CONCLUSIONS. The results of our trial will be very important to know the antiplatelet effect in diabetic patient presented with ST-segment elevation myocardial infarction. While there are several studies assessing the antiplatelet effect of ticagrelor and prasugrel for STEMI, the current study focuses on diabetic patients, which is an important cohort with an higher risk of ischemic events.
Evidences from randomized studies comparing the benefits of Prasugrel and Ticagrelor in patients with STEMI treated with primary PCI give only informations about the comparison with clopidogrel. To our knowledge no prior randomized studies were designed to perform an head-to-head according to the superiority pharmacodynamic effect of Prasugrel versus Ticagrelor (or vice versa) in patients with diabetes mellitus (DM), presented with STEMI and treated with primary PCI. Previous pharmacodynamic studies only measured the platelet reactivity units at 4-6-12 hours after loading dose administration. Considering DM a strong risk factor for major adverse cardiac events, we have chosen, as primary endpoint, an earlier time to compare the two study drugs in order to verify a more rapid effect. In our opinion it is important to know the velocity of action onset of the both drugs immediately after the loading dose administration to avoid the early adverse events as stent thrombosis.
Lesser are the knowledge in STEMI patients with diabetes mellitus about the pharmacodynamic and pharmacokinetics investigation after Prasugrel and Ticagrelor administration. For this reasons our results could add important information to improve the knowledge about pharmacodynamic effects of Prasugrel and Ticagrelor loading dose administration in STEMI patient with DM.
With this future results, clinicians will be advise to individualize decisions regarding the type and modality of dual antiplatelet therapy administration in stented patients. This should be tailored over time on the basis of the clinical profile, the type of stent, and the patient¿s tolerance, comorbidities, and preference.