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Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI: JACC Scientific Expert Panel
Davide Capodanno1, Marie-Claude Morice2, Dominick J Angiolillo3
1Division of Cardiology, Azienda Ospedaliero Universitario "Policlinico G. Rodolico-San Marco", University of Catania, Catania, Italy.
Insights
Balancing thrombotic and bleeding risks after percutaneous coronary intervention (PCI) is crucial for high bleeding risk (HBR) patients. This consensus document provides recommendations for designing clinical trials involving HBR patients undergoing PCI.
Area of Science:
- Cardiology
- Clinical Trial Design
- Interventional Cardiology
Background:
- Patients undergoing percutaneous coronary intervention (PCI) often face a delicate balance between thrombotic and bleeding risks.
- High bleeding risk (HBR) patients represent a vulnerable population requiring specialized clinical trial considerations.
- The Academic Research Consortium for HBR has established a consensus definition to standardize HBR patient identification in trials.
Purpose of the Study:
- To propose evidence-based recommendations for designing clinical trials focused on HBR patients undergoing PCI.
- To guide the development of future trials evaluating drugs and devices in this specific patient group.
- To standardize trial methodologies for assessing outcomes in HBR patients undergoing PCI.
Main Methods:
- Consensus-based document development by the Academic Research Consortium for HBR.
- Review and discussion of existing trial designs for HBR patients undergoing PCI.
- Identification of key aspects for optimizing trial design, including population, interventions, and outcomes.
Main Results:
- The document outlines critical considerations for HBR patient trial design.
- Specific recommendations are provided for target populations, intervention and control groups.
- Guidance is offered on primary and secondary outcomes, and the timing of endpoint reporting.
Conclusions:
- Standardized trial designs are essential for accurately evaluating interventions in HBR patients undergoing PCI.
- The proposed recommendations aim to enhance the quality and relevance of clinical trials in this field.
- This initiative facilitates a more robust understanding of managing thrombotic and bleeding risks in HBR populations.
Abstract:
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.