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

Collegium Medicum w Bydgoszczy

Status

Completed

Conditions

Myocardial Infarction

Treatments

Drug: ticagrelor

Study type

Observational

Funder types

Other

Identifiers

NCT02602444

CMUMK202B

Details and patient eligibility

About

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.

Full 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.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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