Coronary Artery Disease | Effectiveness of Clopidogrel Resinate in PCI(PRIDE)
Coronary Artery Disease research study
What is the primary objective of this study?
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®).
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Coronary Artery Disease
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:Pregrel®Pregrel® 75mg daily for 12 months
Drug:Plavix®Plavix® 75mg daily for 12 months
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.
Start Date: March 15, 2010
Completed Date: March 14, 2017
Phase: Phase 4
Primary Outcome: composite of death (all cause-mortality), MI (Q wave and non Q wave) and stroke
Secondary Outcome: composite of death, MI, stroke, or urgent revascularization
Study sponsors, principal investigator, and references
Principal Investigator: Seung-Jung Park, MD, PhD
Lead Sponsor: Seung-Jung Park
Collaborator: CardioVascular Research Foundation, Korea