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

April 26, 2017 updated by: Jacek Kubica, Collegium Medicum w Bydgoszczy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-094
        • Cardiology Department, Dr. A. Jurasz University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with STEMI or NSTEMI admitted to the study centre, designated to invasive strategy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
STEMI
ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose
Drug: ticagrelor
180 mg loading dose
Other Names:
  • Brilique
NSTEMI
non-ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose
Drug: ticagrelor
180 mg loading dose
Other Names:
  • Brilique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
12 hours
Time to maximum concentration (Cmax) for ticagrelor and AR-C124910XX
Time Frame: 12 hours
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
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
It will be assessed in all predefined time points in all study participants except those treated with GP IIb/IIIa receptor inhibitors.
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
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
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collegium Medicum w Bydgoszczy

Investigators

  • Principal Investigator: Jacek Kubica, MD, PhD, Collegium Medicum, Nicolaus Copernicus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

November 9, 2015

First Submitted That Met QC Criteria

November 9, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUMK202B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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