Plavix, Prasugrel and Drug Eluting Stents Pilot Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine the level of inhibition of platelet activation of an approved thienopyridine(clopidogrel or prasugrel) and aspirin regimen in the setting of drug eluting coronary stent implantation. In subjects with high residual levels of platelet reactivity after receiving either a maintenance or loading dose of either clopidogrel or prasugrel, a cross over of thienopyridine treatment to the alternate medication will occur. The study tests the hypothesis that adequate platelet inhibition will occur in subjects who have high levels of platelet reactivity and are subsequently switched from clopidogrel to prasugrel(loading or maintenance dose) without increased episodes of bleeding or MACE events at discharge and 30 days post Percutaneous Coronary Intervention (PCI).

Official Title
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PPD Trial Pilot Study: Plavix, Prasugrel and Drug Eluting Stents

Conditions
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Coronary Artery Disease, Platelet Aggregation Inhibitors, PCI- Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Loading Dose Arm
* Drug: Maintenance Dose Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject presenting for clinically indicated PCI with implantation of at least one drug-eluting stent. No planned use of Glycoprotein IIb/IIIa inhibitors during PCI procedure. Subject must be taking aspirin or enteric coated aspirin 81 mg-325 mg daily. Willing to participate and sign an informed consent. Exclusion Criteria: Subject older than 75 years of age. Subject weight is 60 kg or less. Subject who have received intravenous eptifibatide or tirofiban within 48 hours prior to PCI or abciximab within 14 days before or during PCI. Subject taking warfarin or with clinical indication to resume warfarin post PCI for any indication. Subject currently requiring daily treatment with NSAID or COX2 inhibitors. Subject with a known platelet disorder. Subject with known active pathological bleeding or heightened risk of bleeding including but not limited to: gastrointestinal bleeding within 6 months, recent surgery or trauma. Subject with a history of a stroke or TIA Subject with pre-PCI hematocrit or platelet count outside the ranges validated for Verify Now P2Y12 test (33-52% and 119.000-502.000/μL, respectively). Subject with a history of hepatic impairment Subject with known NYHA Class III or greater for heart failure. Inability of subject to provide informed consent. Subject with known hypersensitivity or contraindication to clopidogrel, prasugrel or ASA, which would result in inability of patient to adhere to trial protocol. Presence of valvular heart disease left main coronary artery stenosis or urgent need for CABG.

Ages Eligible for Study
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Minimum Age: 21 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Maintenance Dose Arm<br>Open label clopidogrel 75 mg daily or prasugrel 10 mg daily | Drug: Maintenance Dose Arm<br>* Verify Now P2Y12 platelet assay will measure platelet reactivity. Cross over to a loading dose and maintenance dose of alternate medication will occur based on level of platelet reactivity.<br>* Other names: clopidogrel;|
| Active Comparator: Loading Dose Arm<br>Clopidogrel 600 mg or Prasugrel 60 mg at time of PCI. | Drug: Loading Dose Arm<br>* Subjects who are thienopyridine naive will be randomized 1:1 to either clopidogrel 600 mg or prasugrel 60 mg loading dose at the time of PCI. A Verify Now P2Y12 platelet assay will measure platelet reactivity. Cross over to loading dose and maintenance dose of alternate medication will occur based on level of platelet reactivity.<br>* Other names: Verify now P2Y12 platelet assay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in platelet reactivity after switching medication regimen of two thienopyridines- clopidogrel and prasugrel | Platelet reactivity will be measured using the Accumetrics Verify Now P2Y12 platelet assay | 4 hours post medicaton administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of all bleeding events for subjects enrolled into the trial | All bleeding events will be observed, reported and adjudicated by the DSMB | 24 hours post PCI or at time of discharge and 30 days post PCI | 
| Occurrence of all MACE events for subjects enrolled into the trial | All bleeding events will be observed, reported and adjudicated by the DSMB | 24 hours post PCI or at time of discharge and 30 days post PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, clopidogrel, prasugrel, Verify Now, PRU measurements, Drug eluting stents (EDS), P2Y12, Platelet reactivity