Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in STEMI and NSTEMI Patients
PINPOINT
1 other identifier
observational
73
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 9, 2015
CompletedFirst Posted
Study publicly available on registry
November 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedApril 28, 2017
April 1, 2017
1.3 years
November 9, 2015
April 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h)
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)
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)
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)
prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Maximum concentration (Cmax) of ticagrelor and AR-C124910XX
12 hours
Time to maximum concentration (Cmax) for ticagrelor and AR-C124910XX
12 hours
- +4 more secondary outcomes
Study Arms (2)
STEMI
ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose
NSTEMI
non-ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose
Interventions
Eligibility Criteria
Patients with STEMI or NSTEMI admitted to the study centre, designated to invasive strategy.
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiology Department, Dr. A. Jurasz University Hospital
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094, Poland
Related Publications (2)
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.
PMID: 29023473DERIVEDAdamski 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.
PMID: 28446521DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacek Kubica, MD, PhD
Collegium Medicum, Nicolaus Copernicus University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr hab.
Study Record Dates
First Submitted
November 9, 2015
First Posted
November 11, 2015
Study Start
October 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
April 28, 2017
Record last verified: 2017-04