Acute Coronary SyndromePhase 4ticagrelorNCT02341729
Effects and Plasma Concentration of Ticagrelor, After Crushed and Non-crushed Intake, After Acute Coronary Syndrome
A Phase 4 study testing ticagrelor in people with Acute Coronary Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- ticagrelor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2015to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the detailed description
This study is a single-centre, open-label, non-randomised longitudinal study in which the effect of ticagrelor, both crushed and non-crushed will be evaluated in two separate clinical conditions. The plasma concentrations after a crushed intake will be used to determine the maximum plasma concentration and time to achieve this maximum concentration.
50 patients of each condition:
Condition A: patients who received CPR because of cardiac arrest. A gastric tube is inserted. Subjects receive 2 crushed tablets of ticagrelor (180mg) with 10 ml water and a flush of 20 ml water. The first blood sample is taken before administration. The following samples are taken at 30minutes, 1, 2, 4, 8, 12, and 24h. The ninth sample is taken 24 hours after stopping sedation and 4h after administration of ticagrelor with 10 ml water and a flush of 20 ml water via nasogastric tube. The tenth sample is taken 4 days and 4hours after first intake of ticagrelor, this last sample is mostly after a non-crushed intake of ticagrelor (this depends on the neurological condition of the patient). Only the first dose is a loading dose of 180mg, hereafter a normal dose of 90mg is given.
At each blood sampling moment 1 or 2 samples are taken (see also flow chart). At time 0, 2, 4, 8, 12, 24h, 24h after sedation stop and at 4 days and 4hours after first intake of ticagrelor: a Platelet Function Analysis and an Aggreguide aggregometry is done. For each analysis 3,6ml of blood is needed, this makes a total of 28,8ml for the clotting analyses. At time 30min, 1, 2, 4, 8, 24h and 4 days and 4h; 4ml of blood is needed for the plasma concentration measurements, a total of 28ml.
Condition B: Patients in need of semi-urgent coronary bypass surgery, allowing interrupting the administration of ticagrelor 3 days before surgery. A nasogastric tube is inserted during surgery. On intensive care the patients will receive crushed tablets of ticagrelor with 10 ml water and a flush of 20 ml water via gastric tube, the first dose will be a loading dose. The first blood sample is taken just before surgery (weak effect of ticagrelor because administration has stopped 3 days). The following samples are taken at 30minutes, 1, 2, 4, 8, 12, and 24h. The ninth sample is taken 24 hours after stopping sedation and 4h after administration of ticagrelor with 10 ml water and a flush of 20 ml water via nasogastric tube. The tenth sample is taken 4 days and 4hours after first intake of ticagrelor, this last sample is mostly after a non-crushed intake of ticagrelor (this depends on the neurological condition of the patient). Only the first dose is a loading dose of 180mg, hereafter a normal dose of 90mg is given.
At each blood sampling moment 1 or 2 samples are taken (see also flow chart). At time 0, 2, 4, 8, 12, 24h, 24h after sedation stop and at 4 days and 4hours after first intake of ticagrelor: a Platelet Function Analysis and an Aggreguide aggregometry is done. For each analysis 3,6ml of blood is needed, this makes a total of 25,2ml for the clotting analyses. At time 30min, 1, 2, 4, 8, 24h and 4 days and 4h; 4ml of blood is needed for the plasma concentration measurements, a total of 28ml.
- Conditions
- Acute Coronary Syndrome
- Being tested
- ticagrelor
- Keywords
- semi-urgent CABG, reanimation, ticagrelor, crushed tablet
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ticagrelorDrug
Also called Brilique
crushed tablets and non-crushed tablets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Intensievezorgen, University Hospital, Ghent
- Investigators
- Harlinde Peperstraete, MD, Principal investigator, Staff member at Ghent University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341729
- Sponsor's protocol ID
- AGO/2013/011
- Acronym
- ticagrelor
- Status last verified
- May 2021
- First submitted
- 18 Dec 2014
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39377148
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02341729
- Acronym / sponsor ID
- ticagrelor / AGO/2013/011
- Conditions
- Acute Coronary Syndrome
- Keywords
- semi-urgent CABG, reanimation, ticagrelor, crushed tablet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a single-centre, open-label, non-randomised longitudinal study in which the effect of ticagrelor, both crushed and non-crushed will be evaluated in two separate clinical conditions. The plasma concentrations after a crushed intake will be used to determine the maximum plasma concentration and time to achieve this maximum concentration.
50 patients of each condition:
Condition A: patients who received CPR because of cardiac arrest. A gastric tube is inserted. Subjects receive 2 crushed tablets of ticagrelor (180mg) with 10 ml water and a flush of 20 ml water. The first blood sample is taken before administration. The following samples are taken at 30minutes, 1, 2, 4, 8, 12, and 24h. The ninth sample is taken 24 hours after stopping sedation and 4h after administration of ticagrelor with 10 ml water and a flush of 20 ml water via nasogastric tube. The tenth sample is taken 4 days and 4hours after first intake of ticagrelor, this last sample is mostly after a non-crushed intake of ticagrelor (this depends on the neurological condition of the patient). Only the first dose is a loading dose of 180mg, hereafter a normal dose of 90mg is given.
At each blood sampling moment 1 or 2 samples are taken (see also flow chart). At time 0, 2, 4, 8, 12, 24h, 24h after sedation stop and at 4 days and 4hours after first intake of ticagrelor: a Platelet Function Analysis and an Aggreguide aggregometry is done. For each analysis 3,6ml of blood is needed, this makes a total of 28,8ml for the clotting analyses. At time 30min, 1, 2, 4, 8, 24h and 4 days and 4h; 4ml of blood is needed for the plasma concentration measurements, a total of 28ml.
Condition B: Patients in need of semi-urgent coronary bypass surgery, allowing interrupting the administration of ticagrelor 3 days before surgery. A nasogastric tube is inserted during surgery. On intensive care the patients will receive crushed tablets of ticagrelor with 10 ml water and a flush of 20 ml water via gastric tube, the first dose will be a loading dose. The first blood sample is taken just before surgery (weak effect of ticagrelor because administration has stopped 3 days). The following samples are taken at 30minutes, 1, 2, 4, 8, 12, and 24h. The ninth sample is taken 24 hours after stopping sedation and 4h after administration of ticagrelor with 10 ml water and a flush of 20 ml water via nasogastric tube. The tenth sample is taken 4 days and 4hours after first intake of ticagrelor, this last sample is mostly after a non-crushed intake of ticagrelor (this depends on the neurological condition of the patient). Only the first dose is a loading dose of 180mg, hereafter a normal dose of 90mg is given.
At each blood sampling moment 1 or 2 samples are taken (see also flow chart). At time 0, 2, 4, 8, 12, 24h, 24h after sedation stop and at 4 days and 4hours after first intake of ticagrelor: a Platelet Function Analysis and an Aggreguide aggregometry is done. For each analysis 3,6ml of blood is needed, this makes a total of 25,2ml for the clotting analyses. At time 30min, 1, 2, 4, 8, 24h and 4 days and 4h; 4ml of blood is needed for the plasma concentration measurements, a total of 28ml.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| starting with ticagrelor | Other | Drug: ticagrelorPatients, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ticagrelorAlso: Briliquecrushed tablets and non-crushed tablets | Drug | starting with ticagrelor |
Primary outcome
Platelet Function Analysis (closing time) and Aggreguide aggregometry (clotting analyses)
Time frame: 5 days
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.
Plasma concentration measurements : plasma concentrations (using liquid chromatography with mass spectrometry detection)
Time frame: 5 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Derived from this study: PubMed 39377148Duvillier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harlinde Peperstraete, MD principal investigator
Staff member at Ghent University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ticagrelor in people with Acute Coronary Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Function Analysis (closing time) and Aggreguide aggregometry (clotting analyses) (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.