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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard ticagrelor maintenance dose | Active Comparator | Ticagrelor 90 mg twice daily for the first 45 days after myocardial infarction treated with percutaneous coronary intervention. |
|
| Reduced ticagrelor maintenance dose | Experimental | Ticagrelor 90 mg twice daily for the first 30 days after myocardial infarction treated with percutaneous coronary intervention, then reduction of the maintenance dose to ticagrelor 60 mg twice daily for the next 15 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor 90 mg | Drug | Ticagrelor 90 mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Platelet Reactivity Assessed with the VASP assay | Platelet inhibition evaluated with the VASP assay 45 days after myocardial infarction. | 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet Reactivity Assessed with Multiple Electrode Aggregometry | Platelet inhibition evaluated with Multiple Electrode Aggregometry 45 days after myocardial infarction. | 45 days |
| Number of Patients With High Platelet Reactivity according to the VASP assay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Jacek Kubica, MD, PhD | Collegium Medicum im. Ludwika Rydygiera w Bydgoszczy, Uniwersytet Mikołaja Kopernika w Toruniu | Principal Investigator |
| Eliano Navarese, Md, PhD | Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Department, Dr. A. Jurasz University Hospital | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-094 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30689800 | Derived | 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. | |
| 29040445 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Ticagrelor 60 mg | Drug | Ticagrelor 60 mg daily |
|
|
Number of Patients With High Platelet Reactivity according to the VASP assay 45 days after myocardial infarction. |
| 45 days |
| Number of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry | Percentage of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry 45 days after myocardial infarction. | 45 days |
| Plasma concentration of Ticagrelor | Evaluation of ticagrelor plasma concentration 45 days after myocardial infarction. | 45 days |
| Plasma concentration of AR-C124910XX | Evaluation of ticagrelor active metabolite plasma concentration 45 days after myocardial infarction. | 45 days |
| Derived |
| 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. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |