Effects and Plasma Concentration of Ticagrelor, After Crushed and Non-crushed Intake, After Acute Coronary Syndrome

NCT02341729 | Completed Phase 4

• 1 other identifier: AGO/2013/011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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. Gurbel et al. showed that 100% of the patients on ticagrelor treatment have a decrease from baseline platelet aggregation of \>10% 4 hours after last maintenance dose. So the investigators expect that after 3 days of treatment, all of our patients will have a closing time of more than 106seconds. The investigators will observe two different clinical conditions of Acute Coronary Syndrome. First after semi-urgent coronary artery bypass graft (CABG) surgery, secondly in patients after cardiac arrest. Both are clinical situations in which crushed tablets are needed to give. The second objective is to determine plasma concentrations of Ticagrelor and AR-C124910XX (active metabolite of ticagrelor) in these two patient populations after receiving 180mg or 90mg start-dose. Determination of plasma concentrations is done after protein precipitation, by using liquid chromatography with mass spectrometry detection. Measurements will be determined before intake (0h) and at 0,5; 1; 2; 4; 8; 24h and at day 4 +4h.7 The first 24h this will be a crushed tablet and 4 hours after the first intake at day 4 of therapy, this will be a non crushed tablet.

Conditions

Acute Coronary Syndrome

Keywords

semi-urgent CABG; reanimation; ticagrelor; crushed tablet

Outcome Measures

Primary Outcomes (2)

• Platelet Function Analysis (closing time) and Aggreguide aggregometry (clotting analyses)

  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.

  5 days

• Plasma concentration measurements : plasma concentrations (using liquid chromatography with mass spectrometry detection)

  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.

  5 days

Study Arms (1)

starting with ticagrelor

OTHER

Patients, after CPR because of an ACS, will receive 2 crushed tablets of ticagrelor (180mg) through a gastric tube. After this dose twice a day 90mg is given for the duration of 1 year. The 1st blood sample is taken before administration. In total 10 blood samples are taken for determination of platelet aggregation and plasma concentrations. When patients receive a semi-urgent CABG, ticagrelor has been interrupted for 3 days. Postoperative the patients get crushed tablets of ticagrelor, the 1st dose will be 90mg, and every 12h 90mg is given, for the duration of 1 year. The 1st blood sample is taken before the 1st dose. In total 9 blood samples are taken for determination of platelet aggregation and plasma concentrations.

Drug: ticagrelor

Interventions

ticagrelor DRUG

crushed tablets and non-crushed tablets

Also known as: Brilique

starting with ticagrelor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 excipients

Sponsors & Collaborators

• University Hospital, Ghent: lead
• AstraZeneca: collaborator

Study Sites (1)

Intensive Care Unit, Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Publications (1)

• Duvillier L, Verhaege C, Devreese KMJ, Gevaert S, Peperstraete H. Evaluation of the effects and plasma concentration of the platelet inhibitor ticagrelor, after crushed and non-crushed intake, after cardiac arrest and after semi-urgent coronary artery bypass surgery. Acta Cardiol. 2024 Sep;79(7):805-812. doi: 10.1080/00015385.2024.2409521. Epub 2024 Oct 8.

  PMID: 39377148 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Harlinde Peperstraete, MD

  Staff member at Ghent University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Harlinde Peperstraete, Staff member ICU

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: January 19, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

BE (1)