prasugrel-hydrochloride and Cerebral-Infarction

The recent approval of prasugrel will expand the choice of medical treatment. Prasugrel, as a platelet inhibitor, was approved for the management of cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome in 2009. In 2021, it was also approved for use in patients with ischemic stroke. However, there have been cases of patients showing resistance to medical treatment and, therefore, worsening symptoms. It is important to approach treatment while considering the next step. Physicians should be aware of medical treatment choices, including the use of antiplatelet drugs, as well as the appropriate timing to shift to surgical treatment when necessary. In this paper, clinical practice options and guidelines will be considered.

Topics: Atherosclerosis; Cerebral Arteries; Cerebral Infarction; Clopidogrel; Humans; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Stroke; Treatment Outcome

Central adjudication of clinical events in randomized controlled trials represents an attractive but still controversial approach since the adjudicated data usually match well with the investigator-reported event rates but increase affiliated costs.. The aim was to assess the timing of clinical event adjudication in the TRITON trial.. A review of the FDA action package for prasugrel was conducted.. Adjudications for deaths and strokes were distributed evenly throughout the study period. Bleeding event adjudications were performed predominantly in the later stages of the study. Adjudications for myocardial infarction and especially stent thrombosis were significantly delayed.. Among all clinical events, only deaths and strokes in TRITON were adjudicated without delays. Late adjudication of myocardial infarction and stent thrombosis are uncommon but at least can be explained by lack or change of event definitions. However, the delays with adjudications of revascularization procedures and especially timely recording of bleeding complications lack reasonable explanation. The regulatory authorities should consider independent audits when there is a major disagreement between centrally adjudicated and site-reported events influencing the results of a major clinical trial.

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Cerebral Infarction; Clopidogrel; Coronary Restenosis; Data Collection; Disease-Free Survival; Hemorrhage; Myocardial Infarction; Observer Variation; Piperazines; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Randomized Controlled Trials as Topic; Reproducibility of Results; Research Design; Stents; Thiophenes; Ticlopidine; Treatment Outcome; United States; United States Food and Drug Administration