Myocardial InfarctionPINPOINTNCT02602444
Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in STEMI and NSTEMI Patients
An observational study of Myocardial Infarction, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.
Trial summary
The purpose of the PINPOINT study is to compare pharmacokinetics (PK) and pharmacodynamics (PD) of ticagrelor in ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) patients designated to invasive strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- ticagrelor
- How many people
- 73 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2015to Jan 2017
- Phase
- Observational
- 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
Study population: Patients with STEMI or NSTEMI admitted to the study centre, designated to invasive strategy.
Who may be able to join
- provision of informed consent prior to any study specific procedures
- diagnosis of acute ST-segment elevation myocardial infarction or acute non-ST-segment elevation myocardial infarction
- male or non-pregnant female, 18 years old and older
- provision of informed consent for angiography and PCI
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 15Show fewer
- history of coagulation disorders
- history of moderate or severe hepatic impairment
- history of major surgery or severe trauma (within 3 months)
- second or third degree atrioventricular block during screening for eligibility
- patient required dialysis
- manifest infection or inflammatory state
- Killip class III or IV during screening for eligibility
- respiratory failure
- current therapy with strong CYP3A inhibitors or strong CYP3A inducers
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: Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in ST-elevation Myocardial Infarction and Non-ST-elevation Myocardial Infarction Patients
The purpose of the PINPOINT study is to compare pharmacokinetics (PK) and pharmacodynamics (PD) of ticagrelor in ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) patients designated to invasive strategy. Data regarding comparison of PK and antiplatelet action of ticagrelor in STEMI and NSTEMI are sparse. Recommended dosing regimens of ticagrelor are identical for both STEMI and NSTEMI, although it is not known whether PK and PD features of ticagrelor are uniform in these patients.
Read the detailed description
The European Society of Cardiology and American Heart Association guidelines recommend use of ticagrelor or prasugrel as a treatment of choice in patients with both STEMI and NSTEMI (class of recommendation I, level of evidence B). Recommended dosing regimens of ticagrelor are identical in STEMI and NSTEMI patients, although epidemiology, clinical approach and early outcomes differ between these two types of myocardial infarction. It is not known whether PK and PD features of ticagrelor are uniform in STEMI and NSTEMI patients. However, the existing body of evidence suggest that PK and PD of ticagrelor may be attenuated in STEMI patients compared to healthy subjects and patients with stable coronary artery disease, which may expose STEMI patients at increased risk of developing thrombotic complications secondary to insufficient platelet inhibition. The PINPOINT study could provide a valuable insight into the knowledge regarding ticagrelor action in STEMI vs. NSTEMI patients.
Since there is no reference study comparing pharmacokinetics of ticagrelor in STEMI and NSTEMI patients, we decided to perform an internal pilot study of approximately 30 patients (15 patients with each type of myocardial infarction) for estimating the final sample size.
- Conditions
- Myocardial Infarction
- Being tested
- ticagrelor
- Keywords
- ticagrelor, STEMI, NSTEMI, pharmacokinetics, pharmacodynamics
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ticagrelorDrug
Also called Brilique
180 mg loading dose
| Study group | Role | What they receive |
|---|---|---|
| STEMI | ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose Receives: Drug: ticagrelor | |
| NSTEMI | non-ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose Receives: Drug: ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h)
Measured: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose
Secondary outcomes (9)
Area under the plasma concentration-time curve for AR-C124910XX (AUC 0-6h)
Measured: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose
Area under the plasma concentration-time curve for ticagrelor (AUC 0-12h)
Measured: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Area under the plasma concentration-time curve for AR-C124910XX (AUC 0-12h)
Measured: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Maximum concentration (Cmax) of ticagrelor and AR-C124910XX
Measured: 12 hours
Time to maximum concentration (Cmax) for ticagrelor and AR-C124910XX
Measured: 12 hours
Platelet reactivity index (PRI) assessed by VASP assay
Measured: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Platelet reactivity assessed by Multiple Electrode Aggregometry
It will be assessed in all predefined time points in all study participants except those treated with GP IIb/IIIa receptor inhibitors.
Measured: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Percentage of patients with high platelet reactivity (HPR) after the loading dose of ticagrelor assessed with VASP and Multiple Electrode Aggregometry
Measured: 2 hours
Time to reach platelet reactivity below the cut-off value for HPR evaluated with VASP and Multiple Electrode Aggregometry
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 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, Collegium Medicum, Nicolaus Copernicus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602444
- Sponsor's protocol ID
- CMUMK202B
- Acronym
- PINPOINT
- Status last verified
- Apr 2017
- First submitted
- 9 Nov 2015
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Adamski P, Sikora J, Laskowska E, Buszko K, Ostrowska M, Uminska JM, Sikora A, Skibinska N, Sobczak P, Adamska U, Rosc D, Kubica A, Paciorek P, Marszall MP, Navarese EP, Gorog DA, Kubica J. Comparison of bioavailability and antiplatelet action of ticagrelor in patients with ST-elevation myocardial infarction and non-ST-elevation myocardial infarction: A prospective, observational, single-centre study. PLoS One. 2017 Oct 12;12(10):e0186013. doi: 10.1371/journal.pone.0186013. eCollection 2017.
PubMed 29023473Adamski P, Ostrowska M, Sikora J, Obonska K, Buszko K, Krintus M, Sypniewska G, Marszall MP, Kozinski M, Kubica J. Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in STEMI and NSTEMI Patients (PINPOINT): protocol for a prospective, observational, single-centre study. BMJ Open. 2017 Apr 26;7(4):e013218. doi: 10.1136/bmjopen-2016-013218.
PubMed 28446521
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in ST-elevation Myocardial Infarction and Non-ST-elevation Myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT02602444
- Acronym / sponsor ID
- PINPOINT / CMUMK202B
- Conditions
- Myocardial Infarction
- Keywords
- ticagrelor, STEMI, NSTEMI, pharmacokinetics, pharmacodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Collegium Medicum w BydgoszczyUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 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 the PINPOINT study is to compare pharmacokinetics (PK) and pharmacodynamics (PD) of ticagrelor in ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) patients designated to invasive strategy. Data regarding comparison of PK and antiplatelet action of ticagrelor in STEMI and NSTEMI are sparse. Recommended dosing regimens of ticagrelor are identical for both STEMI and NSTEMI, although it is not known whether PK and PD features of ticagrelor are uniform in these patients.
Detailed description
The European Society of Cardiology and American Heart Association guidelines recommend use of ticagrelor or prasugrel as a treatment of choice in patients with both STEMI and NSTEMI (class of recommendation I, level of evidence B). Recommended dosing regimens of ticagrelor are identical in STEMI and NSTEMI patients, although epidemiology, clinical approach and early outcomes differ between these two types of myocardial infarction. It is not known whether PK and PD features of ticagrelor are uniform in STEMI and NSTEMI patients. However, the existing body of evidence suggest that PK and PD of ticagrelor may be attenuated in STEMI patients compared to healthy subjects and patients with stable coronary artery disease, which may expose STEMI patients at increased risk of developing thrombotic complications secondary to insufficient platelet inhibition. The PINPOINT study could provide a valuable insight into the knowledge regarding ticagrelor action in STEMI vs. NSTEMI patients.
Since there is no reference study comparing pharmacokinetics of ticagrelor in STEMI and NSTEMI patients, we decided to perform an internal pilot study of approximately 30 patients (15 patients with each type of myocardial infarction) for estimating the final sample size.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEMI | – | Drug: ticagrelorST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose |
| NSTEMI | – | Drug: ticagrelornon-ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with STEMI or NSTEMI admitted to the study centre, designated to invasive strategy.
Key inclusion criteria (4 listed)
- provision of informed consent prior to any study specific procedures
- diagnosis of acute ST-segment elevation myocardial infarction or acute non-ST-segment elevation myocardial infarction
- male or non-pregnant female, 18 years old and older
- provision of informed consent for angiography and PCI
Key exclusion criteria (15 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 |
|---|---|---|
| ticagrelorAlso: Brilique180 mg loading dose | Drug | NSTEMI, STEMI |
Primary outcome
Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h)
Time frame: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose
9 secondary outcomes
Area under the plasma concentration-time curve for AR-C124910XX (AUC 0-6h)
Time frame: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose
Area under the plasma concentration-time curve for ticagrelor (AUC 0-12h)
Time frame: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Area under the plasma concentration-time curve for AR-C124910XX (AUC 0-12h)
Time frame: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Maximum concentration (Cmax) of ticagrelor and AR-C124910XX
Time frame: 12 hours
Time to maximum concentration (Cmax) for ticagrelor and AR-C124910XX
Time frame: 12 hours
Platelet reactivity index (PRI) assessed by VASP assay
Time frame: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Platelet reactivity assessed by Multiple Electrode Aggregometry
Time frame: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Percentage of patients with high platelet reactivity (HPR) after the loading dose of ticagrelor assessed with VASP and Multiple Electrode Aggregometry
Time frame: 2 hours
Time to reach platelet reactivity below the cut-off value for HPR evaluated with VASP and Multiple Electrode Aggregometry
Time frame: 12 hours
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 28 Apr 2017.
- Derived from this study: PubMed 29023473Adamski P, Sikora J, Laskowska E, Buszko K, Ostrowska M, Uminska JM, Sikora A, Skibinska N, Sobczak P, Adamska U, Rosc D, Kubica A, Paciorek P, Marszall MP, Navarese EP, Gorog DA, Kubica J. Comparison of bioavailability and antiplatelet action of ticagrelor in patients with ST-elevation myocardial infarction and non-ST-elevation myocardial infarction: A prospective, observational, single-centre study. PLoS One. 2017 Oct 12;12(10):e0186013. doi: 10.1371/journal.pone.0186013. eCollection 2017.
- Derived from this study: PubMed 28446521Adamski P, Ostrowska M, Sikora J, Obonska K, Buszko K, Krintus M, Sypniewska G, Marszall MP, Kozinski M, Kubica J. Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in STEMI and NSTEMI Patients (PINPOINT): protocol for a prospective, observational, single-centre study. BMJ Open. 2017 Apr 26;7(4):e013218. doi: 10.1136/bmjopen-2016-013218.
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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
Collegium Medicum, Nicolaus Copernicus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, 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 4 inclusion and 15 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 28 Apr 2017. 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.
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?
Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h) (time frame: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose). 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 NCT02602444, which also lists 2 linked publications.
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 28 Apr 2017.