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Effectiveness of Clopidogrel Resinate in PCI(PRIDE)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pregrel®
Plavix®
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring antiplatelet therapy post drug eluting stents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Gangneung Asan Hospital
  • Asan Medical Center
  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pregrel®

Plavix®

Arm Description

clopidogrel

clopidogrel

Outcomes

Primary Outcome Measures

composite of death (all cause-mortality), MI (Q wave and non Q wave) and stroke

Secondary Outcome Measures

composite of death, MI, stroke, or urgent revascularization
Individual components of death, MI, stroke, or urgent revascularization
The need for target vessel revascularization or any revascularization
The incidence of early discontinuation of study drugs
The incidence of major bleeding events
Stent thrombosis
composite of death, MI, stroke, or urgent revascularization
composite of death, MI, stroke, or urgent revascularization
Individual components of death, MI, stroke, or urgent revascularization
Individual components of death, MI, stroke, or urgent revascularization
Individual components of death, MI, stroke, or urgent revascularization
The incidence of major bleeding events
The incidence of major bleeding events
The incidence of early discontinuation of study drugs
The incidence of early discontinuation of study drugs
Stent thrombosis
Stent thrombosis

Full Information

First Posted
April 22, 2011
Last Updated
June 15, 2017
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01349777
Brief Title
Effectiveness of Clopidogrel Resinate in PCI(PRIDE)
Official Title
Effectiveness of Clopidogrel Resinate(PRegrel®) in Patients Undergoing Percutaneous Coronary Intervention Compared With ClopiDogrEl Bisulfate(Plavix®)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 15, 2010 (Actual)
Primary Completion Date
March 14, 2017 (Actual)
Study Completion Date
March 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
antiplatelet therapy post drug eluting stents

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1056 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregrel®
Arm Type
Experimental
Arm Description
clopidogrel
Arm Title
Plavix®
Arm Type
Active Comparator
Arm Description
clopidogrel
Intervention Type
Drug
Intervention Name(s)
Pregrel®
Other Intervention Name(s)
clopidogrel
Intervention Description
Pregrel® 75mg daily for 12 months
Intervention Type
Drug
Intervention Name(s)
Plavix®
Other Intervention Name(s)
clopidogrel 75mg
Intervention Description
Plavix® 75mg daily for 12 months
Primary Outcome Measure Information:
Title
composite of death (all cause-mortality), MI (Q wave and non Q wave) and stroke
Time Frame
12 months
Secondary Outcome Measure Information:
Title
composite of death, MI, stroke, or urgent revascularization
Time Frame
12 months
Title
Individual components of death, MI, stroke, or urgent revascularization
Time Frame
at discharge
Title
The need for target vessel revascularization or any revascularization
Time Frame
12 months
Title
The incidence of early discontinuation of study drugs
Time Frame
30 days
Title
The incidence of major bleeding events
Time Frame
30 days
Title
Stent thrombosis
Time Frame
30 days
Title
composite of death, MI, stroke, or urgent revascularization
Time Frame
30 days
Title
composite of death, MI, stroke, or urgent revascularization
Time Frame
6 months
Title
Individual components of death, MI, stroke, or urgent revascularization
Time Frame
30 days
Title
Individual components of death, MI, stroke, or urgent revascularization
Time Frame
6 months
Title
Individual components of death, MI, stroke, or urgent revascularization
Time Frame
12 months
Title
The incidence of major bleeding events
Time Frame
6 months
Title
The incidence of major bleeding events
Time Frame
12 months
Title
The incidence of early discontinuation of study drugs
Time Frame
6 months
Title
The incidence of early discontinuation of study drugs
Time Frame
12 months
Title
Stent thrombosis
Time Frame
6 months
Title
Stent thrombosis
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Jung Park, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangneung Asan Hospital
City
Gangneung
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is not a publicly funded trial.

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Effectiveness of Clopidogrel Resinate in PCI(PRIDE)

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