Coronary Artery Disease | Plavix, Prasugrel and Drug Eluting Stents Pilot Trial
Coronary Artery Disease research study
What is the primary objective of this study?
- 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).
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Coronary Artery Disease
Platelet Aggregation Inhibitors
PCI- Percutaneous Coronary Intervention
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Loading Dose ArmSubjects 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.
Drug:Maintenance Dose ArmVerify 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Maintenance Dose ArmOpen label clopidogrel 75 mg daily or prasugrel 10 mg daily
Loading Dose ArmClopidogrel 600 mg or Prasugrel 60 mg at time of PCI.
Start Date: April 2010
Completed Date: May 2011
Primary Outcome: Change in platelet reactivity after switching medication regimen of two thienopyridines- clopidogrel and prasugrel
Secondary Outcome: Occurrence of all bleeding events for subjects enrolled into the trial
Study sponsors, principal investigator, and references
Principal Investigator: Richard A Shlofmitz, MD
Lead Sponsor: St. Francis Hospital, New York
Brandt JT, Close SL, Iturria SJ, Payne CD, Farid NA, Ernest CS 2nd, Lachno DR, Salazar D, Winters KJ. Common polymorphisms of CYP2C19 and CYP2C9 affect the pharmacokinetic and pharmacodynamic response to clopidogrel but not prasugrel. J Thromb Haemost. 2007 Dec;5(12):2429-36. Epub 2007 Sep 26.