… a National Heart, Lung, and Blood Institute–sponsored symposium we were asked to evaluate
clinical trials of hemostatic products in cardiac surgery and mechanical circulatory support …

… Bleeding is therefore a central safety outcome in cardiovascular clinical trials. … within a
trial depending on which bleeding definition is used. Examples include analyses from the …

… for clinical trials and to complement clinical decision-making … consensus document represents
the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials …

… clinical trials and regulatory pathways in the last decade. The consensus-based end point
definitions … of this document and strongly advocated for clinical trial purposes. This Academic …

… intended to establish consensus on the definition, classification, and … to clinical trials of a
broad range of cardiovascular interventions. Systematic application of the proposed definitions …

… The goal of this document is to provide a framework of definitions for CV and stroke outcomes
in clinical trials to … These definitions are based on published medical data; clinical and …

… These criteria, generated in the context of a collaboration among leading research … clinical
practice or future clinical trials as well as the regulatory pathways for both drugs and devices. …

… Results of clinical trials are properly interpretable and comparable if and only if … consensus
on the definition of the study endpoints. There have been various initiatives for standardizing …

… risk of major adverse cardiovascular events compared with those where DAPT cessation
was not physician-guided. In the context of a clinical trial, the NARC consensus was to clearly …

… In particular, the use of an anticoagulant in the presence of single- or dual-antiplatelet therapy
is a significant risk factor for bleeding and a rapidly evolving area in terms of clinical trials …