effectiveness of clopidogrel resinate in pci(pride)

Conditions: Coronary Artery Disease

Summary: this study is an open label, multi-center, randomized trial, which is designed to evaluate the efficacy and safety of clopidogrel derivative (pregrel®) therapy for 12 months in patients undergoing pci compared to conventional clopidogrel (plavix®).

prospective, two arms, randomized multi-center trial of 1,056 patients enrolled at 3 centers in korea. following angiography, patients with significant diameter stenosis \>50% by visual estimation have documented myocardial ischemia or symptoms of angina and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) pregrel® group vs. b) plavix®. this trial is the non-inferiority study to demonstrate that the incidence of 12 months primary end-point in pregrel® group.

Eligibility criteria:
inclusion criteria: * the patient must be at least 18 years of age. * patients with symptomatic coronary artery disease with objective evidence of ischemia (e.g. symptoms of angina pectoris, positive stress test results, or dynamic ecg changes). * patients are referred for pci, or thought to be at high likelihood for requiring stent placement with or without conventional balloon angioplasty * the patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site. exclusion criteria: * the patient has a known hypersensitivity or contraindication to any of the following medications: * heparin * aspirin * both clopidogrel and ticlopidine * stainless steel and/or * contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenylhydramine \[e.g. rash\] may be enrolled. patients with true anaphylaxis to prior contrast media, however, should not be enrolled). * coronary anatomy not amenable to stent placement * female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study. * history of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions. * gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months. * current known current platelet count \<100,000 cells/mm3 or hgb \<10 g/dl. * an elective major surgical procedure is planned that would necessitate interruption of thienopyridines during the first 1 year post enrollment. * non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment). * patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. * administration of the following medications prior to randomization: gpiib-iiia inhibitor and clopidogrel within 7 days (already received pretreatment), or thrombolytics within 24 hours. * long-term (at least \> 3 months) use or requirement of nsaid or anticoagulation * patients with cardiogenic shock * acute mi patients within symptom onset \< 12 hours needing primary angioplasty * patients with left main stem stenosis (\>50% by visual estimate)

Keywords: antiplatelet therapy post drug eluting stents