Effectiveness of Clopidogrel Resinate in PCI(PRIDE)

This study is currently recruiting participants.
Verified August 2012 by CardioVascular Research Foundation, Korea
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01349777
First received: April 22, 2011
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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®).


Condition Intervention Phase
Coronary Artery Disease
Drug: Pregrel®
Drug: Plavix®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness of Clopidogrel Resinate(PRegrel®) in Patients Undergoing Percutaneous Coronary Intervention Compared With ClopiDogrEl Bisulfate(Plavix®)

Resource links provided by NLM:


Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • composite of death (all cause-mortality), MI (Q wave and non Q wave) and stroke [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • composite of death, MI, stroke, or urgent revascularization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Individual components of death, MI, stroke, or urgent revascularization [ Time Frame: at discharge ] [ Designated as safety issue: Yes ]
  • The need for target vessel revascularization or any revascularization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The incidence of early discontinuation of study drugs [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • The incidence of major bleeding events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • composite of death, MI, stroke, or urgent revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • composite of death, MI, stroke, or urgent revascularization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Individual components of death, MI, stroke, or urgent revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Individual components of death, MI, stroke, or urgent revascularization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Individual components of death, MI, stroke, or urgent revascularization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • The incidence of major bleeding events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • The incidence of major bleeding events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • The incidence of early discontinuation of study drugs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The incidence of early discontinuation of study drugs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1056
Study Start Date: April 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregrel®
clopidogrel
Drug: Pregrel®
Pregrel® 75mg daily for 12 months
Other Name: clopidogrel
Active Comparator: Plavix®
clopidogrel
Drug: Plavix®
Plavix® 75mg daily for 12 months
Other Name: clopidogrel 75mg

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349777

Contacts
Contact: Seung-Jung Park Park, MD, PhD (82-2)-3010-4812 sjpark@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
  More Information

No publications provided

Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01349777     History of Changes
Other Study ID Numbers: 2009-0483
Study First Received: April 22, 2011
Last Updated: August 7, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by CardioVascular Research Foundation, Korea:
antiplatelet therapy post drug eluting stents

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014