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.