Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments pregrel®, plavix®
Phase phase 4
Sponsor Seung-Jung Park
Collaborator CardioVascular Research Foundation, Korea
Start date April 2010
End date February 2017
Trial size 1056 participants
Trial identifier NCT01349777, 2009-0483

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®).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
clopidogrel
pregrel® clopidogrel
Pregrel® 75mg daily for 12 months
(Active Comparator)
clopidogrel
plavix® clopidogrel 75mg
Plavix® 75mg daily for 12 months

Primary Outcomes

Measure
composite of death (all cause-mortality), MI (Q wave and non Q wave) and stroke
time frame: 12 months

Secondary Outcomes

Measure
composite of death, MI, stroke, or urgent revascularization
time frame: 12 months
Individual components of death, MI, stroke, or urgent revascularization
time frame: at discharge
The need for target vessel revascularization or any revascularization
time frame: 12 months
The incidence of early discontinuation of study drugs
time frame: 30 days
The incidence of major bleeding events
time frame: 30 days
Stent thrombosis
time frame: 30 days
composite of death, MI, stroke, or urgent revascularization
time frame: 30 days
composite of death, MI, stroke, or urgent revascularization
time frame: 6 months
Individual components of death, MI, stroke, or urgent revascularization
time frame: 30 days
Individual components of death, MI, stroke, or urgent revascularization
time frame: 6 months
Individual components of death, MI, stroke, or urgent revascularization
time frame: 12 months
The incidence of major bleeding events
time frame: 6 months
The incidence of major bleeding events
time frame: 12 months
The incidence of early discontinuation of study drugs
time frame: 6 months
The incidence of early discontinuation of study drugs
time frame: 12 months
Stent thrombosis
time frame: 6 months
Stent thrombosis
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Effectiveness of Clopidogrel Resinate(PRegrel®) in Patients Undergoing Percutaneous Coronary Intervention Compared With ClopiDogrEl Bisulfate(Plavix®)
Principal investigator Seung-Jung Park, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by CardioVascular Research Foundation, Korea.