Coronary Artery Disease
Conditions
Keywords
antiplatelet therapy post drug eluting stents
Brief 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®).
Detailed description
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.
Interventions
DRUGPregrel®
Pregrel® 75mg daily for 12 months
DRUGPlavix®
Plavix® 75mg daily for 12 months
Sponsors
CardioVascular Research Foundation, Korea
Seung-Jung Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite of death (all cause-mortality), MI (Q wave and non Q wave) and stroke | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Individual components of death, MI, stroke, or urgent revascularization | at discharge |
| The need for target vessel revascularization or any revascularization | 12 months |
| composite of death, MI, stroke, or urgent revascularization | 12 months |
| The incidence of major bleeding events | 30 days |
| Stent thrombosis | 30 days |
| The incidence of early discontinuation of study drugs | 30 days |
Countries
South Korea
Outcome results
None listed