Effectiveness of Clopidogrel Resinate in PCI(PRIDE)

• Status: Completed
• Trial end date: 2017-03-14
• Target enrollment: 0
• Participant gender: All

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®).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seung-Jung Park
• Collaborator: CardioVascular Research Foundation, Korea
• Treatments: Clopidogrel; Ticlopidine

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)