Clinical trial NCT03251859: Effectiveness of Lower Maintenance Dose of Ticagrelor Early After Myocardial Infarction (ELECTRA) Pilot Study
Official title: A Randomized, Open-label, Pharmacodynamic and Pharmacokinetic Trial Assessing the Effect of Lowering Ticagrelor Maintenance Dose Early After Myocardial Infarction on Platelet Inhibition (ELECTRA Pilot Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Keywords: platelet reactivity
ticagrelor
myocardial infarction
pharmacodynamics
antiplatelet therapy
Lead sponsor: Collegium Medicum w Bydgoszczy
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ELECTRA pilot study is a randomized, open-label, pharmacokinetic and pharmacodynamic trial designed to evaluate the effect of ticagrelor maintenance dose reduction on platelet inhibition in stable patients who recently underwent acute myocardial infarction and were treated with percutaneous coronary intervention.


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 according to the Third Universal Definition of Myocardial Infarction
* index event treatment with percutaneous coronary intervention
* male or non-pregnant female, aged 18-80 years old

Exclusion Criteria:

* contraindications for ticagrelor
* further coronary revascularization planned during the first 45 days after myocardial infarction
* indications for chronic treatment with oral anticoagulant or 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)
* active neoplastic disease
* patient requiring dialysis
* chronic inflammatory disease
* current therapy with strong CYP3A inhibitors or strong CYP3A inducers

Primary outcomes:
measure: Platelet Reactivity Assessed with the VASP assay
timeFrame: 45 days
Secondary outcomes:
measure: Platelet Reactivity Assessed with Multiple Electrode Aggregometry
timeFrame: 45 days
measure: Number of Patients With High Platelet Reactivity according to the VASP assay
timeFrame: 45 days
measure: Number of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry
timeFrame: 45 days
measure: Plasma concentration of Ticagrelor
timeFrame: 45 days
measure: Plasma concentration of AR-C124910XX
timeFrame: 45 days
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Cardiology Department, Dr. A. Jurasz University Hospital
state: Kujawsko-pomorskie
Study officials:
affiliation: Collegium Medicum im. Ludwika Rydygiera w Bydgoszczy, Uniwersytet Mikołaja Kopernika w Toruniu
name: Prof. Jacek Kubica, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
name: Eliano Navarese, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kubica J, Adamski P, Buszko K, Baranska M, Sikora J, Marszall MP, Sobczak P, Sikora A, Kuliczkowski W, Fabiszak T, Kubica A, Jilma B, Alexopoulos D, Navarese EP. Platelet inhibition with standard vs. lower maintenance dose of ticagrelor early after myocardial infarction (ELECTRA): a randomized, open-label, active-controlled pharmacodynamic and pharmacokinetic study. Eur Heart J Cardiovasc Pharmacother. 2019 Jul 1;5(3):139-148. doi: 10.1093/ehjcvp/pvz004.
citation: Kubica J, Adamski P, Buszko K, Kubica A, Kuliczkowski W, Fabiszak T, Jilma B, Alexopoulos D, Paciorek P, Navarese EP. Rationale and Design of the Effectiveness of LowEr maintenanCe dose of TicagRelor early After myocardial infarction (ELECTRA) pilot study. Eur Heart J Cardiovasc Pharmacother. 2018 Jul 1;4(3):152-157. doi: 10.1093/ehjcvp/pvx032.