As the use of cardiovascular Chinese patent medicine increases, the phenomenon of off-label drug use is being more and more common. Off-label drug use is one of the important sources of new discoveries that is of certain clinical rationality and necessity. For its scientific and standardized application, however, the premise is to ensure the patient’s medication safety and standardize the off-label drug use. This study draws on the concept and method of evidence-based medicine, with cardiovascular Chinese patent medicine as a breakthrough point, providing the off-label use of cardiovascular Chinese patent medicine with methodological support through exploring the method and procedure of establishing the evidence-based evaluation of the off-label drug use of cardiovascular Chinese patent medicine.