Effectiveness of Clopidogrel Resinate in PCI(PRIDE)

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

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®).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Pregrel®; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 1056
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangneung, Korea, Republic of
    • Gangneung Asan Hospital
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pregrel®; clopidogrel	Drug: Pregrel®; Pregrel® 75mg daily for 12 months; Other Names: clopidogrel
Active Comparator: Plavix®; clopidogrel	Drug: Plavix®; Plavix® 75mg daily for 12 months; Other Names: clopidogrel 75mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Stent thrombosis	30 days
Stent thrombosis	6 months
Stent thrombosis	12 months
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
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

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2010
• Primary Completion (Actual): March 14, 2017
• Study Completion (Actual): March 14, 2017

Study Registration Dates

• First Submitted: April 22, 2011
• First Submitted That Met QC Criteria: May 6, 2011
• First Posted (Estimate): May 9, 2011

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: antiplatelet therapy post drug eluting stents
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: 2009-0483

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not a publicly funded trial.