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Cangrelor safety and pharmacodynamics in paediatric subjects with congenital heart disease
EU CTIS ID: 2025-523109-14-00
What this study is testing
To evaluate the safety profile of the recommended dosing regimen of Cangrelor in the paediatric population.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- Corrected age of <37 weeks at screening
- 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
- Platelet count less than 150,000 cells/µL or higher than 450,000 cells/µL at screening
- Known allergy to Cangrelor or known sensitivity to any component of Cangrelor
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.