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Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in STEMI and NSTEMI Patients (PINPOINT)

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ClinicalTrials.gov Identifier: NCT02602444
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Jacek Kubica, Collegium Medicum w Bydgoszczy

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.

Condition or disease Intervention/treatment
Myocardial Infarction Drug: ticagrelor

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.

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Study Type : Observational
Actual Enrollment : 73 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in ST-elevation Myocardial Infarction and Non-ST-elevation Myocardial Infarction Patients
Actual Study Start Date : October 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Ticagrelor

Group/Cohort Intervention/treatment
STEMI
ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose
Drug: ticagrelor
180 mg loading dose
Other Name: Brilique

NSTEMI
non-ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose
Drug: ticagrelor
180 mg loading dose
Other Name: Brilique




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Maximum concentration (Cmax) of ticagrelor and AR-C124910XX [ Time Frame: 12 hours ]
  5. Time to maximum concentration (Cmax) for ticagrelor and AR-C124910XX [ Time Frame: 12 hours ]
  6. 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 ]
  7. Platelet reactivity assessed by Multiple Electrode Aggregometry [ Time Frame: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose ]
    It will be assessed in all predefined time points in all study participants except those treated with GP IIb/IIIa receptor inhibitors.

  8. 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 ]
  9. Time to reach platelet reactivity below the cut-off value for HPR evaluated with VASP and Multiple Electrode Aggregometry [ Time Frame: 12 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with STEMI or NSTEMI admitted to the study centre, designated to invasive strategy.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602444


Locations
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Poland
Cardiology Department, Dr. A. Jurasz University Hospital
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-094
Sponsors and Collaborators
Collegium Medicum w Bydgoszczy
Investigators
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Principal Investigator: Jacek Kubica, MD, PhD Collegium Medicum, Nicolaus Copernicus University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jacek Kubica, Prof. dr hab., Collegium Medicum w Bydgoszczy
ClinicalTrials.gov Identifier: NCT02602444    
Other Study ID Numbers: CMUMK202B
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Keywords provided by Jacek Kubica, Collegium Medicum w Bydgoszczy:
ticagrelor
STEMI
NSTEMI
pharmacokinetics
pharmacodynamics
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs