Thrombosis, thromboembolism MedDRA version: 14.1 Level: PT Classification code 10050661 Term: Platelet aggregation inhibition System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: ticagrelor 45 mg, tablets
Product Code: AZD6140
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ticagrelor
CAS Number: 274693-5
Current Sponsor code: AZD6140
Other descripti
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable EU guidelines Patients aged 12 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Sign or suspicion of extra-vascular bleeding in connection with placement of the CVC (>24 hours need to have elapsed since any sign or suspicion of ongoing bleeding, in order to allow randomisation of the patient). Patients who have an ongoing bleeding, risk of bleeding, previous intracranial haemorrhage, or platelet count <100,000 x 109/L. Surgery within 7 days unless judged to be a low risk for bleeding and at least 24 hours after surgery. Patients who are taking aspirin or other non-steroidal anti-inflammatory drugs within a week before randomisation and during the study period. Patients who are taking ADP receptor blockers (eg, clopidogrel, prasugrel,ticlopidine), dipyridamole, and cilostazol within a week before randomisation and during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the pharmacodynamics of ticagrelor (45 mg bd), measured as the final extent of inhibition of platelet aggregation in paediatric patients aged from 12 to <18 years of age.;Secondary Objective: To examine the pharmacokinetic profile of ticagrelor in paediatric patients 12 to <18 years of age. To evaluate the relationship between ticagrelor exposure and platelet aggregation inhibition. To assess the safety and tolerability of ticagrelor in patients aged 12 to <18 years of age with a central venous catheter by evaluation of adverse events, including bleeding events. To evaluate the relationship between inhibition of platelet aggregation and platelet reactivity index by determining the platelet reactivity index. ;Primary end point(s): Pharmacodynamics of ticagrelor:Final extent of inhibition of platelet aggregation(IPA). IPA will be assessed via light transmission aggregometry of platelet rich plasma with 3.2% sodium citrate as the anticoagulant and 20 umol/L of ADP as the agonist. ;Timepoint(s) of evaluation of this end point: On days 1 and 5 as well as after 2 day's follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): #1) To examine the pharmacokinetic profile of ticagrelor by assessment of maximum concentration, time to maximum concentration, area under the plasma time concentration curve and accumulation ratio #2) To evaluate the relationship between ticagrelor exposure and platelet aggregation inhibition (IPA) #3) To assess the safety and tolerability ticagrelor by assessment of adverse events (AEs) including bleeding, laboratory values, physical examination, vital signs and ECG #4) To evaluate the relationship between inhibition of platelet aggregation (IPA) and platelet reactivity index (PRI). PRI will be determined by measurement of vasodilator-stimulated phosphoprotein phosphorylation (VASP-P);Timepoint(s) of evaluation of this end point: #1) On days 1 and 5 #2) On days 1 and 5 #3) AEs during the study, lab and vital signs at baseline, day 5 and 2 day's follow-up, phys exam at baseline and 2 days' follow-up, ECG at baseline, days 1 and 5, 2 day's follow-up #4) On days 1 and 5 as well as after 2 day's follow-up | — |
Countries
Canada, Czech Republic, France, Germany, Hungary
Contacts
Public ContactInformation Center
AstraZeneca
Outcome results
None listed