Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in STEMI and NSTEMI Patients

NCT ID: NCT02602444

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 73 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-01-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

STEMI

ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose

ticagrelor

Intervention Type: DRUG

180 mg loading dose

NSTEMI

non-ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose

ticagrelor

Intervention Type: DRUG

180 mg loading dose

Interventions

ticagrelor

180 mg loading dose

Intervention Type: DRUG

Other Intervention Names

Brilique

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Collegium Medicum w Bydgoszczy

OTHER

Sponsor Role: lead

Responsible Party

Jacek Kubica

Prof. dr hab.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacek Kubica, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Collegium Medicum, Nicolaus Copernicus University

Locations

Cardiology Department, Dr. A. Jurasz University Hospital

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 29023473 (View on PubMed)

Adamski 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.

Reference Type: DERIVED

PMID: 28446521 (View on PubMed)

Other Identifiers

CMUMK202B

Identifier Type: -

Identifier Source: org_study_id