Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI
Résumé
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. (C) 2020 by the American College of Cardiology Foundation.
Mots clés
Renal Guard Solutions
and the Scott R. MacKenzie Foundation. Dr. Bhatt is an Advisory Board member for Cardax
Cereno Scientific
Elsevier Practice Update Cardiology
Afimmune
Amarin
Boehringer Ingelheim
Bristol-Myers Squibb
Cardax
Chiesi
Ethicon
Ferring Pharmaceuticals
Forest Laboratories
Fractyl
Ironwood
Ischemix
Lexicon
Medtronic
Pfizer
PhaseBio
PLx Pharma
Regeneron
Roche
Sanofi
Synaptic
and The Medicines Company
has received royalties from Elsevier
high bleeding risk
percutaneous coronary intervention
trial design
Amgen
AstraZeneca
Bayer
Biosensors
CeloNova
CSL Behring
Daiichi-Sankyo
Eisai
Eli Lilly
Gilead
Idorsia
Janssen
Matsutani Chemical Industry
Merck
Novartis
Osprey Medical
Domaines
Médecine humaine et pathologie
Origine : Fichiers produits par l'(les) auteur(s)
