Cangrelor safety and pharmacodynamics in paediatric subjects with congenital heart disease

Ki vehet részt

• Males and females aged from birth to less than 18 years
• Diagnosis of CHD, including, but not limited to, patent ductus arteriosus, coarctation of aorta, atrial septal defect, ventricular septal defects, valvular stenosis
• Expected to undergo a diagnostic and/or therapeutic percutaneous vascular procedure
• Female subjects fulfilling one of the following criteria: • Women of non-childbearing potential (WONCBP), defined as physiologically incapable of becoming pregnant; • Women of childbearing potential (WOCBP) fulfilling one of the following criteria: o Sexually active: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the end of the follow-up period (Day 4/discharge) o Non-sexually active (contraception is not required in this case)
• Male subjects fulfilling one of the following criteria: • Non-fertile male subjects (contraception is not required in this case); • Fertile male subjects without a female partner (contraception is not required in this case); • Fertile male subjects with any WOCBP partner: they must be willing to use male condom from the signature of the informed consent and until the end of the follow-up period (Day 4/discharge); • Fertile male subjects with WONCBP partner (contraception is not required in this case)

Ki nem vehet részt

• History of intracerebral bleeding or cerebral arteriovenous malformation; or evidence of any prior bleeding with neurological deficit
• Gastrointestinal or genitourinary bleeding within the last 2 weeks prior to screening, excluding normal menstrual cycles
• Known allergy to Cangrelor or known sensitivity to any component of Cangrelor
• Platelet count less than 150,000 cells/µL or higher than 450,000 cells/µL at screening
• Corrected age of <37 weeks at screening