Effectiveness of Clopidogrel Resinate in PCI(PRIDE)

NCT01349777 | Completed Phase 4 DMC

• 1 other identifier: 2009-0483
• Study Type: interventional
• Target: 1,056
• Locations: 1 country
• Sites: 3

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®).

Conditions

Coronary Artery Disease

Keywords

antiplatelet therapy post drug eluting stents

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (17)

• 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

Study Arms (2)

Pregrel®

EXPERIMENTAL

clopidogrel

Drug: Pregrel®

Plavix®

ACTIVE COMPARATOR

clopidogrel

Drug: Plavix®

Interventions

Pregrel® DRUG

Pregrel® 75mg daily for 12 months

Also known as: clopidogrel

Pregrel®

Plavix® DRUG

Plavix® 75mg daily for 12 months

Also known as: clopidogrel 75mg

Plavix®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (3)

Gangneung Asan Hospital

Gangneung, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Seung-Jung Park, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Study Record Dates

• First Submitted: April 22, 2011
• First Posted: May 9, 2011
• Study Start: March 15, 2010
• Primary Completion: March 14, 2017
• Study Completion: March 14, 2017
• Last Updated: June 16, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)