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.

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. - Ticagrelor-study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004191-35-BE

Enrollment

100

Registered

2014-10-30

Start date

2014-11-28

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 17.1 Level: LLT Classification code 10063919 Term: Bypass surgery System Organ Class: 100000004865 MedDRA version: 17.1 Level: PT Classification code 10007515 Term: Cardiac arrest System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Brilique 90 mg, filmomhulde tabletten Product Name: Ticagrelor Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ticagrelor Other descriptive name: TICAGRELOR Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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 =65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: Not applicable	—

Primary

Measure	Time frame
Main Objective: The first aim of the study is to prove that after starting the therapy with crushed tablets, the platelet inhibition will be as expected after starting therapy with intact tablets. ;Secondary Objective: The second objective is to determine plasma concentrations of Ticagrelor and AR-C124910XX in these two patient populations after receiving 180mg or 90mg start-dose. ;Primary end point(s): Test the platelet inhibition by a Platelet Function Analyser on all blood samples.;Timepoint(s) of evaluation of this end point: After all blood sampling is performed.	—

Measure

Time frame

Main Objective: The first aim of the study is to prove that after starting the therapy with crushed tablets, the platelet inhibition will be as expected after starting therapy with intact tablets. ;Secondary Objective: The second objective is to determine plasma concentrations of Ticagrelor and AR-C124910XX in these two patient populations after receiving 180mg or 90mg start-dose. ;Primary end point(s): Test the platelet inhibition by a Platelet Function Analyser on all blood samples.;Timepoint(s) of evaluation of this end point: After all blood sampling is performed.

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Countries

Belgium

Contacts

Public ContactBimetra Clinics

Ghent University Hospital

Bimetra.Clinics@uzgent.be+3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026