Effectiveness of Clopidogrel Resinate in PCI(PRIDE)

Study Overview
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Brief Summary
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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®).

Detailed Description
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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.

Official Title
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Effectiveness of Clopidogrel Resinate(PRegrel®) in Patients Undergoing Percutaneous Coronary Intervention Compared With ClopiDogrEl Bisulfate(Plavix®)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Pregrel®
* Drug: Plavix®


Participation Criteria
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Eligibility Criteria
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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)

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregrel®<br>clopidogrel | Drug: Pregrel®<br>* Pregrel® 75mg daily for 12 months<br>* Other names: clopidogrel;|
| Active Comparator: Plavix®<br>clopidogrel | Drug: Plavix®<br>* Plavix® 75mg daily for 12 months<br>* Other names: clopidogrel 75mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite of death (all cause-mortality), MI (Q wave and non Q wave) and stroke |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite of death, MI, stroke, or urgent revascularization |  | 12 months | 
| Individual components of death, MI, stroke, or urgent revascularization |  | at discharge | 
| The need for target vessel revascularization or any revascularization |  | 12 months | 
| The incidence of early discontinuation of study drugs |  | 30 days | 
| The incidence of major bleeding events |  | 30 days | 
| Stent thrombosis |  | 30 days | 
| composite of death, MI, stroke, or urgent revascularization |  | 30 days | 
| composite of death, MI, stroke, or urgent revascularization |  | 6 months | 
| Individual components of death, MI, stroke, or urgent revascularization |  | 30 days | 
| Individual components of death, MI, stroke, or urgent revascularization |  | 6 months | 
| Individual components of death, MI, stroke, or urgent revascularization |  | 12 months | 
| The incidence of major bleeding events |  | 6 months | 
| The incidence of major bleeding events |  | 12 months | 
| The incidence of early discontinuation of study drugs |  | 6 months | 
| The incidence of early discontinuation of study drugs |  | 12 months | 
| Stent thrombosis |  | 6 months | 
| Stent thrombosis |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antiplatelet therapy post drug eluting stents