Unstable Angina PectorisPhase 4NCT02612116
Comparison of Administration Strategies of Ticagrelor in Patients With Unstable Angina Pectoris, a Pharmacokinetic / Pharmacodynamic Study
A Phase 4 study testing Pulverized ticagrelor sublingually, Pulverized ticagrelor orally and Integral ticagrelor in people with Unstable Angina Pectoris, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.
Trial summary
The purpose of this study is to evaluate the differences in pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite depending on the strategy of the drug administration in patients with unstable angina pectoris. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unstable Angina Pectoris
- What is being tested?
- Pulverized ticagrelor sublingually, Pulverized ticagrelor orally and Integral ticagrelor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2015to Sep 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Diagnosis of unstable angina
- Male or non-pregnant female, aged 18-80 years old
- Provision of informed consent for angiography and percutaneous coronary intervention (PCI)
- GRACE score <140 pts
Who cannot join
- treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
- hypersensitivity to ticagrelor
- current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
- active bleeding
- history of intracranial hemorrhage
- recent gastrointestinal bleeding (within 30 days)
Show all 21Show fewer
- history of coagulation disorders
- platelet count less than <100 x10^3/mcl
- hemoglobin concentration less than 10.0 g/dl
- history of moderate or severe hepatic impairment
- history of major surgery or severe trauma (within 3 months)
- patients considered by the investigator to be at risk of bradycardic events
- second or third degree atrioventricular block during screening for eligibility
- history of asthma or severe chronic obstructive pulmonary disease
- patient requiring dialysis
- manifest infection or inflammatory state
- Killip class III or IV during screening for eligibility
- respiratory failure
- history of severe chronic heart failure (NYHA class III or IV)
- concomitant therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir) or strong CYP3A inducers (rifampicin, phenytoin, carbamazepine, dexamethasone, phenobarbital) within 14 days and during study treatment
- body weight below 50 kg
Trial locations and contacts
1 site in 1 country.
Poland1 site
Cardiology Department, Dr. A. Jurasz University Hospital
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094
About this study
Official title: The Impact of Administration Strategy of Ticagrelor on Its Pharmacokinetics and Pharmacodynamics in Patients With Unstable Angina Pectoris - a Randomized, Single-center, Open-label Pilot Study
The purpose of this study is to evaluate the differences in pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite depending on the strategy of the drug administration in patients with unstable angina pectoris.
Read the detailed description
On the basis of the current guidelines ticagrelor is a recommended antiplatelet agent in acute coronary syndromes, including unstable angina pectoris.
According to the results of the MOJITO study, performed in patients with ST-elevation myocardial infarction, the effect of ticagrelor, measured as platelet inhibition, may be achieved sooner when crushed tablets are administered. Thus, there may be significant differences in pharmacokinetics and pharmacodynamics of ticagrelor if pulverized drug is given orally or sublingually when compared with currently used oral administration of integral tablets.
The study is designed as an open-label, single-center, randomized trial of different strategies of administration of ticagrelor in patients with unstable angina pectoris. After enrollment, the participants will be randomized into three arms, each receiving ticagrelor. The drug will be given in: (1) pulverized tablets administered sublingually, (2) pulverized tablets administered orally or in (3) integral tablets orally. The time required for ticagrelor and its active metabolite AR-C124900XX to reach their maximum serum concentration will be measured as the primary outcome of the study. Moreover, further evaluation of other parameters including maximum plasma concentration and area under the plasma concentration of ticagrelor and its active metabolite will be assessed as secondary outcomes. The platelet reactivity will be measured with the Multiplate Analyzer.
- Conditions
- Unstable Angina Pectoris
- Being tested
- Pulverized ticagrelor sublingually, Pulverized ticagrelor orally, Integral ticagrelor
- Medical subject headings
- Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulverized ticagrelor sublinguallyDrug
Also called Brilique
Pulverized ticagrelor (180 mg) administered sublingually
Pulverized ticagrelor orallyDrug
Also called Brilique
Pulverized ticagrelor (180 mg) administered orally
Integral ticagrelorDrug
Also called Brilique
Integral ticagrelor (180 mg) administered orally
| Study group | Role | What they receive |
|---|---|---|
| pulverized ticagrelor sublingually | Active comparator | Pulverized ticagrelor 180 mg (Brilique) administered sublingually Receives: Drug: Pulverized ticagrelor sublingually |
| pulverized ticagrelor orally | Active comparator | Pulverized ticagrelor 180 mg (Brilique) administered orally Receives: Drug: Pulverized ticagrelor orally |
| Integral ticagrelor orally | Active comparator | Ticagrelor 180 mg (Brilique) administered orally in integral tablets Receives: Drug: Integral ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to maximum concentration (tmax) for ticagrelor and AR-C124900XX
Measured: 6 hours
Secondary outcomes (4)
Maximum ticagrelor and AR-C124900XX concentration
Measured: 6 hours
Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h)
Measured: prior to the initial dose and 15 min, 30 min, 45 min, 1, 2, 3, 4, 6 hours post dose
Area under the plasma concentration-time curve for AR-C124900XX (AUC 0-6h)
Measured: prior to the initial dose and 15 min, 30 min, 45 min, 1, 2, 3, 4, 6 hours post dose
Platelet reactivity assessed by Multiple Electrode Aggregometry
Measured: prior to the initial dose and 30min, 1, 2, 3, 4, 6 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable Angina PectorisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collegium Medicum w Bydgoszczy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacek Kubica, Collegium Medicum w Bydgoszczy
- Investigators
- Jacek Kubica, MD., PhD., Principal investigator, Cardiology Department, Dr. A. Jurasz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612116
- Sponsor's protocol ID
- CMUMK202D
- Status last verified
- Oct 2016
- First submitted
- 19 Nov 2015
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Administration Strategy of Ticagrelor on Its Pharmacokinetics and Pharmacodynamics in Patients With Unstable Angina Pectoris - a Randomized, Single-center, Open-label Pilot Study
- ClinicalTrials.gov ID
- NCT02612116
- Acronym / sponsor ID
- CMUMK202D
- Conditions
- Unstable Angina Pectoris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Collegium Medicum w BydgoszczyUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 23 Nov 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 purpose of this study is to evaluate the differences in pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite depending on the strategy of the drug administration in patients with unstable angina pectoris.
Detailed description
On the basis of the current guidelines ticagrelor is a recommended antiplatelet agent in acute coronary syndromes, including unstable angina pectoris.
According to the results of the MOJITO study, performed in patients with ST-elevation myocardial infarction, the effect of ticagrelor, measured as platelet inhibition, may be achieved sooner when crushed tablets are administered. Thus, there may be significant differences in pharmacokinetics and pharmacodynamics of ticagrelor if pulverized drug is given orally or sublingually when compared with currently used oral administration of integral tablets.
The study is designed as an open-label, single-center, randomized trial of different strategies of administration of ticagrelor in patients with unstable angina pectoris. After enrollment, the participants will be randomized into three arms, each receiving ticagrelor. The drug will be given in: (1) pulverized tablets administered sublingually, (2) pulverized tablets administered orally or in (3) integral tablets orally. The time required for ticagrelor and its active metabolite AR-C124900XX to reach their maximum serum concentration will be measured as the primary outcome of the study. Moreover, further evaluation of other parameters including maximum plasma concentration and area under the plasma concentration of ticagrelor and its active metabolite will be assessed as secondary outcomes. The platelet reactivity will be measured with the Multiplate Analyzer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pulverized ticagrelor sublingually | Active comparator | Drug: Pulverized ticagrelor sublinguallyPulverized ticagrelor 180 mg (Brilique) administered sublingually |
| pulverized ticagrelor orally | Active comparator | Drug: Pulverized ticagrelor orallyPulverized ticagrelor 180 mg (Brilique) administered orally |
| Integral ticagrelor orally | Active comparator | Drug: Integral ticagrelorTicagrelor 180 mg (Brilique) administered orally in integral tablets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of informed consent prior to any study specific procedures
- Diagnosis of unstable angina
- Male or non-pregnant female, aged 18-80 years old
- Provision of informed consent for angiography and percutaneous coronary intervention (PCI)
- GRACE score <140 pts
Key exclusion criteria (21 listed)
- treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
- hypersensitivity to ticagrelor
- current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
- active bleeding
- history of intracranial hemorrhage
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 |
|---|---|---|
| Pulverized ticagrelor sublinguallyAlso: BriliquePulverized ticagrelor (180 mg) administered sublingually | Drug | pulverized ticagrelor sublingually |
| Pulverized ticagrelor orallyAlso: BriliquePulverized ticagrelor (180 mg) administered orally | Drug | pulverized ticagrelor orally |
| Integral ticagrelorAlso: BriliqueIntegral ticagrelor (180 mg) administered orally | Drug | Integral ticagrelor orally |
Primary outcome
Time to maximum concentration (tmax) for ticagrelor and AR-C124900XX
Time frame: 6 hours
4 secondary outcomes
Maximum ticagrelor and AR-C124900XX concentration
Time frame: 6 hours
Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h)
Time frame: prior to the initial dose and 15 min, 30 min, 45 min, 1, 2, 3, 4, 6 hours post dose
Area under the plasma concentration-time curve for AR-C124900XX (AUC 0-6h)
Time frame: prior to the initial dose and 15 min, 30 min, 45 min, 1, 2, 3, 4, 6 hours post dose
Platelet reactivity assessed by Multiple Electrode Aggregometry
Time frame: prior to the initial dose and 30min, 1, 2, 3, 4, 6 hours post 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 19 Oct 2016.
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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.
Jacek Kubica, MD., PhD. principal investigator
Cardiology Department, Dr. A. Jurasz 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 Pulverized ticagrelor sublingually, Pulverized ticagrelor orally and Integral ticagrelor in people with Unstable Angina Pectoris, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.
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 5 inclusion and 21 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 19 Oct 2016. 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 Poland. 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?
Time to maximum concentration (tmax) for ticagrelor and AR-C124900XX (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2016.