A study to determine how much ticagrelor needs to be given to children and adolescents with a central venous catheter.

Phase 1

• Conditions: Thrombosis, thromboembolism; MedDRA version: 16.0Level: PTClassification code 10050661Term: Platelet aggregation inhibitionSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-002896-32-FR
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-19
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 18

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 <18 years with a central venous catheter (CVC) with intended use for at least 5 days at
time of randomisation.
All post-menarche females are required to have a negative pregnancy test. Male and female patients are to adhere to appropriate contraceptive measures (if appropriate to the age of the child).
Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified