Effects and Plasma Concentration of Ticagrelor, After Crushed and Non-crushed Intake, After Acute… (NCT02341729) | Clinical Trial Compass
CompletedPhase 4
Effects and Plasma Concentration of Ticagrelor, After Crushed and Non-crushed Intake, After Acute Coronary Syndrome
Belgium40 participantsStarted 2015-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \< 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
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 excipients
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared crushed versus whole ticagrelor tablets after acute coronary syndrome — if I have trouble swallowing pills, is crushing ticagrelor a medically accepted option for me based on what this study found?
2The trial measured how quickly and effectively ticagrelor was absorbed in the bloodstream using plasma concentration testing — what did the results suggest about whether crushing the tablet changes how fast the drug works, and does that matter for my specific situation?
3Since this was a Phase 4 study, meaning ticagrelor was already approved when it was tested, does the existing safety and effectiveness data from this trial give my care team enough confidence to recommend one form of administration over the other for me?
4The trial used platelet function and clotting analyses as its main measurements — based on those findings, is there a meaningful clinical difference in how well my platelets are controlled depending on whether I take the tablet whole or crushed?
5Given that this trial is now completed, has my doctor seen or reviewed its findings, and could those results influence which formulation or delivery method they'd recommend for my antiplatelet therapy after acute coronary syndrome?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Platelet Function Analysis (closing time) and Aggreguide aggregometry (clotting analyses)
Timeframe: 5 days
2
Plasma concentration measurements : plasma concentrations (using liquid chromatography with mass spectrometry detection)