Evaluation of the effects and plasma concentration of the potent platelet inhibitor ticagrelor, after crushed and non-crushed intake, after semi-urgent coronary bypass and in patients after cardiac arrest.
- Conditions
- Group A: Patients who received CPR because of cardiac arrest.Group B: Patients in need of semi-urgent coronary bypass surgery, allowing interrupting the administration of ticagrelor 3 days before surgery.MedDRA version: 17.1Level: LLTClassification code 10063919Term: Bypass surgerySystem Organ Class: 100000004865MedDRA version: 17.1Level: PTClassification code 10007515Term: Cardiac arrestSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-004191-35-BE
- Lead Sponsor
- Ghent University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
•Subject with an acute myocardial infarction with ST elevation
•Subject with an acute myocardial infarction without ST elevation
•Subject with unstable angina (progressive angina during past 2 weeks, negative cardiac markers, Trop T < 0,014µg/l
•First time of taking Brilique
•= 18 years
•Possibility to take a blood sample before administration of Brilique
•Signed Informed Consent, signed by subject or authorized representative, able and willing to provide written informed consent for study participation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
•Active haemorrhage
•Moderate or severe liver failure with coagulopathy
•Pregnancy and lactation
•A history of an intra cerebral haemorrhage
•Patient is HIV positive and treated with Ritonavir and /or Atazanavir
•Patient treated with vitamin K antagonist or with a new oral anti coagulant
•Hypersensitivity to ticagrelor or any of the exipients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method