Rapid Activity of Platelet Inhibitor Drugs Study

Study Overview
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Brief Summary
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The aim of the RAPID study is to assess the rapid onset of action of the 2 novel oral antiplatelet agents, Prasugrel and Ticagrelor, in 50 patients with STEMI undergoing PPCI with bivalirudin monotherapy.

Detailed Description
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Fifty consecutive patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed ) will be randomized to receive 60 mg Prasugrel loading dose (n= 25) or 180 Ticagrelor loading dose (n= 25) before PPCI. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the 2 hours after drug loading dose a new loading dose will be administered. All interventions will be performed by the femoral approach according to current standards. The use of thrombectomy before infarct-related artery stenting, of everolimus eluting stent and of closure devices will be strongly encouraged. Bivalirudin will be administered as a bolus 0.75 mg/kg followed by 1.75 mg/kg/h infusion during PCI. After PCI a reduced bivalirudin infusion of 0.25 mg/kg/h for 4 hours will be allowed. Dual antiplatelet therapy (100 mg aspirin associated with 5 or 10 mg Prasugrel or 180 mg Ticagrelor) will be recommended for 12 months. Residual platelet reactivity will be assessed in all patients at baseline (time of loading dose), and after 2, 4, 8 and 12 hours by a point-of-care test VerifyNow bedside available in the Intensive cardiac care Unit. High residual platelet reactivity will be defined as a Platelet Reactivity Units (PRU) > 240 by VerifyNow. At the same time point, Activated Clotting Time (ACT) will be also assessed. Follow-up will be performed by outpatient visits or telephone interviews at 6 months.

Official Title
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Rapid Activity of Platelet Inhibitor Drugs Study

Conditions
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ST-segment Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Prasugrel
* Drug: Ticagrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting within 12 hours from the onset of symptoms with STEMI Informed, written consent Exclusion Criteria: Age < 18 years Active bleeding; bleeding diathesis; coagulopathy History of gastrointestinal or genitourinary bleeding <2 months Major surgery in the last 6 weeks History of intracranial bleeding or structural abnormalities Suspected aortic dissection Any previous TIA/stroke Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux, GPI. Known relevant hematological deviations: Hb <10 g/dl, Platelet count <100x10^9/l Use of coumadin derivatives within the last 7 days Chronic therapy with prasugrel or ticagrelor Known malignancies or other comorbid conditions with life expectancy <1 year Known severe liver disease, severe renal failure Known allergy to the study medications Pregnancy

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: 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> | Drug: Prasugrel<br>* 25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed ) will be enrolled to receive 60 mg Prasugrel loading dose before PPCI. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the 2 hours after drug loading dose a new loading dose will be administered.<br>|
| Active Comparator: Ticagrelor Loading dose<br> | Drug: Ticagrelor<br>* 25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed ) will be enrolled to receive 180 Ticagrelor loading dose before PPCI. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the 2 hours after drug loading dose a new loading dose will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual platelet reactivity by VerifyNow | Residual platelet reactivity will be assessed in all patients at baseline (time of loading dose), and after 2 hours by a point-of-care test VerifyNow bedside available in the Intensive cardiac care Unit. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High residual platelet reactivity | High residual platelet reactivity will be defined as a Platelet Reactivity Units (PRU) > 240 by VerifyNow. | 2,4,8,12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet inhibitor, ST-segment elevation myocardial infarction, stent, prasugrel, ticagrelor