Platelet Sub-study of the Neomindset Trial

Study Overview
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Brief Summary
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The general purpose of the Neomindset trial is to evaluate the non-inferiority hypothesis for ischemic events and the superiority hypothesis for bleeding events resulting from platelet P2Y12 receptor inhibitors given as monotherapy in comparison with conventional dual antiplatelet therapy in acute coronary syndrome patients treated with percutaneous coronary intervention. The platelet sub-study will be conducted at the Hospital Israelita Albert Einstein. This sub-study will recruit randomized patients from the Neomindset trial to evaluate platelet function after at least 30 days of study treatment with either P2Y12 inhibitor monotherapy or dual antiplatelet therapy.

Detailed Description
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The platelet sub-study will be conducted at the Hospital Israelita Albert Einstein. This sub-study will recruit randomized patients from the Neomindset trial to evaluate platelet function after at least 30 days of study treatment with either P2Y12 inhibitor monotherapy or dual antiplatelet therapy. These patients will undergo blood sampling and measurement of platelet function after being treated with P2Y12 inhibitor monotherapy or dual antiplatelet therapy for at least 30 days.

Official Title
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Platelet Function Evaluation in Patients With Acute Coronary Syndromes on Potent P2Y12 Inhibitor Monotherapy Versus Dual Antiplatelet Therapy With Aspirin and a Potent P2Y12 Inhibitor

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Dual antiplatelet therapy: Acetylsalicylic acid + ticagrelor OR Acetylsalicylic acid + prasugrel
* Drug: Monotherapy: Ticagrelor alone OR Prasugrel alone


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age >=18 years; Clinical presentation compatible with acute coronary syndrome with onset < 24 hours before admission; Successful percutaneous coronary intervention(s) of all target lesions (culprit and non-culprit) with new-generation drug-eluting stents; Length of stay in hospital at randomization < 96 hours; Subjects will be informed about the nature of the study and must agree to comply and give an informed consent in writing using a form approved in advance by the local Ethics Committee. Exclusion Criteria: Acute coronary syndrome on index admission treated in a conservative way or by unsuccessful percutaneous intervention or surgically; Presence of residual lesions which are likely to require future treatment in the next 12 months; Fibrinolytic therapy < 24 hour before randomization; Need of oral anticoagulation with warfarin or new anticoagulants; Chronic bleeding diathesis; Active or recent major bleeding (in-hospital); Prior intracranial hemorrhage; Ischemic cerebrovascular accident < 30 days; Presence of brain arteriovenous malformation; Index event of non-atherothrombotic etiology (i.e., stent thrombosis, coronary embolism, spontaneous coronary artery dissection, myocardial ischemia due to supply/demand imbalance); Potential or scheduled cardiac or non-cardiac surgery in the next 12 months; Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3; Total white blood count < 3,000 cells/mm3; Suspected or documented active liver disease (including laboratory evidence of hepatitis B or C); Receiver of heart transplant; Known allergies or intolerance of acetylsalicylic acid, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin or antiproliferative agents from the limus-family of drugs; Subject with life expectation lower than 1 year; Any significant medical condition that, in the investigator's opinion, could interfere with the ideal participation of the subject in the study; Participation in other study in the past 12 months, unless a direct benefit to the subject can be expected. Impossibility of being treated with dual antiplatelet therapy for 12 months, based on investigator judgement.

Ages Eligible for Study
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Minimum Age: 18 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetylsalicylic acid + ticagrelor OR Acetylsalicylic acid + prasugrel<br>Subjects randomized to Dual Antiplatelet Therapy Control Group will be treated with a regimen of acetylsalicylic acid combined with ticagrelor or prasugrel for 12 months. Acetylsalicylic acid (100 mg/day) + ticagrelor (90 mg twice daily) Or Acetylsalicylic acid (100 mg/day) + prasugrel (10 mg once daily) | Drug: Dual antiplatelet therapy: Acetylsalicylic acid + ticagrelor OR Acetylsalicylic acid + prasugrel<br>* Acetylsalicylic acid (100 mg/day) + ticagrelor (90 mg twice daily) Or Acetylsalicylic acid (100 mg/day) + prasugrel (10 mg once daily)<br>|
| Experimental: Ticagrelor alone or prasugrel alone<br>All subjects randomized to Monotherapy Group will have acetylsalicylic acid discontinued immediately after randomization. Subjects randomized to Monotherapy Group will be treated with ticagrelor (90 mg twice daily) or prasugrel alone (10 mg once daily) for 12 months. Ticagrelor alone (90 mg twice daily) Or Prasugrel alone (10 mg once daily) | Drug: Monotherapy: Ticagrelor alone OR Prasugrel alone<br>* Ticagrelor alone (90 mg twice daily) OR Prasugrel alone (10 mg once daily)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet function using PFA-100 | Platelet function using PFA-100 | 30 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet function using CHRONO-LOG | Platelet function using CHRONO-LOG | 30 days of treatment | 
| Platelet function using Rotem-platelet | Platelet function using Rotem-platelet | 30 days of treatment | 
| Coagulation test using thromboelastogram | Coagulation test using thromboelastogram | 30 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute coronary syndrome, antithrombotic therapy, dual antiplatelet therapy, monotherapy