Effectiveness of Lower Maintenance Dose of Ticagrelor Early After Myocardial Infarction (ELECTRA) Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Ticagrelor 90 mg
* Drug: Ticagrelor 60 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard ticagrelor maintenance dose<br>Ticagrelor 90 mg twice daily for the first 45 days after myocardial infarction treated with percutaneous coronary intervention. | Drug: Ticagrelor 90 mg<br>* Ticagrelor 90 mg twice daily<br>* Other names: Brilique 90 mg;|
| Experimental: Reduced ticagrelor maintenance dose<br>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. | Drug: Ticagrelor 90 mg<br>* Ticagrelor 90 mg twice daily<br>* Other names: Brilique 90 mg;Drug: Ticagrelor 60 mg<br>* Ticagrelor 60 mg daily<br>* Other names: Brilique 60 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet reactivity, ticagrelor, myocardial infarction, pharmacodynamics, antiplatelet therapy