PraSugrel vs TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus

Study Overview
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Brief Summary
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Dual antiplatelet therapy is essential in patients following ST-Elevation myocardial infarction (STEMI) with percutaneous coronary intervention (PCI) and drug eluting stent implantation. Current guidelines recommend prasugrel and ticagrelor in patients with STEMI undergoing primary PPCI. We sought to investigate the superiority antiplatelet effect in terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg) in diabetic patients with STEMI undergoing primary PCI at 1 and 2 hours post drug administration. Secondary end-points will be: PR level measured at 6 and 12 hours post study drugs administrationin hospital. All consecutive diabetic patients with STEMI undergoing PPCI with stent implantation will be considered for PR assessment at 1-2-6-12 h after the drug LD administration. All patients must will be naïve for platelet P2Y12 receptor inhibition therapy. A subanalysis will be performed between two study groups according to insulin treatment.

Official Title
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Prasugrel Or Ticagrelor In ST-Elevation Myocardial Infarction Patients With Diabetes Mellitus

Conditions
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ST-Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: ticagrelor
* Drug: prasugrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetic patients acute coronary syndrome patients underwent to primary PCI naïve for platelet P2Y12 receptor inhibition therapy Exclusion Criteria: history of bleeding diathesis chronic oral anticoagulation treatment contraindications to antiplatelet therapy PCI or coronary artery bypass grafting (CABG) < 3 months hemodynamic instability platelet count < 100,000/μl hematocrit < 30% creatinine clearance < 25 ml/min Patients with a history of stroke contraindication for prasugrel administration patients weighing < 60 kg patients treated with morphine > 75 years of age.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prasugrel loading dose<br>Patients will be randomized to this arm to receive loading dose of prasugrel | Drug: ticagrelor<br>* Patients will be randomized to this arm to receive loading dose of ticagrelor<br>Drug: prasugrel<br>* Patients will be randomized to this arm to receive loading dose of prasugrel<br>|
| No Intervention: ticagrelor loading dose<br>Patients will be randomized to this arm to receive loading dose of ticagrelor | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the superiority antiplatelet effect in terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg) in diabetic patients with STEMI undergoing primary PCI at 2 hours post drug administration. |  | 1 and 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PR level measured at 6 and 12 hours post study drugs administration. |  | in hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, antiplatelet effect, prasugrel, ticagrelor, STEMI, Insulin