Effectiveness of Clopidogrel Resinate in PCI(PRIDE)

NCT ID: NCT01349777

Last Updated: 2017-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1056 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-15
• Study Completion Date: 2017-03-14

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pregrel®

clopidogrel

Group Type: EXPERIMENTAL

Pregrel®

Intervention Type: DRUG

Pregrel® 75mg daily for 12 months

Plavix®

clopidogrel

Group Type: ACTIVE_COMPARATOR

Plavix®

Intervention Type: DRUG

Plavix® 75mg daily for 12 months

Interventions

Pregrel®

Pregrel® 75mg daily for 12 months

Intervention Type: DRUG

Plavix®

Plavix® 75mg daily for 12 months

Intervention Type: DRUG

Other Intervention Names

clopidogrel; clopidogrel 75mg

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role: collaborator

Seung-Jung Park

OTHER

Sponsor Role: lead

Responsible Party

Seung-Jung Park

MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Seung-Jung Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Gangneung Asan Hospital

Gangneung, , South Korea

Asan Medical Center

Seoul, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Countries

South Korea

Other Identifiers

2009-0483

Identifier Type: -

Identifier Source: org_study_id