Why the study?
Following the Academic Research Consortium consensus definition to standardize the high bleeding risk (HBR) population, recommendations were needed to guide the design of clinical trials evaluating devices and drugs in HBR patients undergoing PCI.
This consensus document provides standardized recommendations for designing clinical trials involving high bleeding risk patients undergoing PCI.
Promotes standardized trial design in HBR-PCI patients; extends prior ARC consensus to improve future evidence quality.
Investigating the balance of risk for thrombotic and bleeding events after percutaneous coronary intervention (PCI) is especially relevant for patients at high bleeding risk (HBR). The Academic Research Consortium for HBR recently proposed a consensus definition in an effort to standardize the patient population included in HBR trials. The aim of this consensus-based document, the second initiative from the Academic Research Consortium for HBR, is to propose recommendations to guide the design of clinical trials of devices and drugs in HBR patients undergoing PCI. The authors discuss the designs of trials in HBR patients undergoing PCI and various aspects of trial design specific to HBR patients, including target populations, intervention and control groups, primary and secondary outcomes, and timing of endpoint reporting.
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Capodanno et al. (2020) conducted a review in High bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). Trial design recommendations was evaluated. The Academic Research Consortium for High Bleeding Risk proposes consensus recommendations to guide the design of clinical trials for devices and drugs in HBR patients undergoing PCI.
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