Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents

NCT00947843 | Completed Phase 4

• 1 other identifier: KOPRE-DM/CAD
• Study Type: interventional
• Target: 306
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the efficacy and tolerability between clopidogrel resinate and clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD equivalents.

Conditions

Coronary Heart Disease

Keywords

CHD; CHD equivalents

Outcome Measures

Primary Outcomes (1)

• The percentage of P2Y12 receptor inhibition assessed by Ultegra rapid platelet function analyzer, (Baseline platelet reaction unit (PRU)- posttreatment PRU)/Baseline PRU * 100 (%))

  1 month

Secondary Outcomes (1)

• Adverse events after study medication

  1 month

Study Arms (3)

aspirin+placebo

PLACEBO COMPARATOR

aspirin protect (Bayer) 100mg + placebo clopidogrel 75mg for 1mo

Drug: aspirin + placebo

aspirin+pregrel

ACTIVE COMPARATOR

pregrel is a generic brand name of clopidogrel

Drug: aspirin + pregrel (Clopidogrel resinate)

Aspirin+Plavix

ACTIVE COMPARATOR

plavix is a original brand name of clopidogrel

Drug: aspirin + plavix (Clopidogrel bisulfate)

Interventions

aspirin + pregrel (Clopidogrel resinate) DRUG

Also known as: Aspirin: Aspirin Protect (Bayer) 100mg, Pregrel: Clopidogrel resinate (CKD Pharmaceutical) 75mg

aspirin+pregrel

aspirin + placebo DRUG

aspirin+placebo

aspirin + plavix (Clopidogrel bisulfate) DRUG

Also known as: aspirin : Aspirin Protect (Bayer) 100mg, plavix : Clopidogrel bisulfate (Sanofi-Aventis) 75mg

Aspirin+Plavix

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Korean men and women aged 20 to 85 years with coronary heart disease (CHD) or CHD equivalent patients
• Atherosclerotic plaques in coronary computed tomography (CT) or angiography or
• History of PCI or coronary artery bypass graft surgery (CABG) \> one year or
• Diabetes mellitus (including type I and type II) or
• Confirmed carotid atherosclerotic plaque with sonography, CT or angiography or
• History of peripheral artery disease or
• History of cerebrovascular disease

You may not qualify if:

• Patients who had history of PCI within one year
• Patients who used concomitant anticoagulants
• Patients who had hypersensitivity to aspirin or clopidogrel, serious bleeding tendency, history of intracranial hemorrhage, sign of active bleeding, uncontrolled hypertension
• Chronic alcoholism or drug addiction
• Women who were pregnant or breastfeeding or who were not using an effective method of contraception
• The use of glycoprotein IIb/IIIa inhibitor, daily NSAIDs, lipid lowering agent (except atorvastatin), or substances with possible interactions with the study drug

Sponsors & Collaborators

• Seoul National University Hospital: lead
• CKD Pharmaceutical Limited: collaborator

Related Publications (1)

• Suh JW, Seung KB, Gwak CH, Kim KS, Hong SJ, Park TH, Kim SH, Choi YJ, Joo SJ, Tahk SJ, Kim HS. Comparison of antiplatelet effect and tolerability of clopidogrel resinate with clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD-equivalent risks: a phase IV, prospective, double-dummy, parallel-group, 4-week noninferiority trial. Clin Ther. 2011 Aug;33(8):1057-68. doi: 10.1016/j.clinthera.2011.07.001. Epub 2011 Aug 4.

  PMID: 21816478 DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

Aspirin; clopidogrel resinate; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ki-Bae Seung, MD, PhD

  Seoul St. Mary's Hospital

  STUDY DIRECTOR

• Chung-Hwan Gwak, MD, PhD

  Gyeongsang National University Hospital

  STUDY DIRECTOR

• Kwon-Sam Kim, MD,PhD

  Kyung Hee University Hospital

  STUDY DIRECTOR

• Soon-Jun Hong, MD,PhD

  Korea University Anam Hospital

  STUDY DIRECTOR

• Tae-Ho Park, MD,PhD

  Dong-A medical center

  STUDY DIRECTOR

• Sang-Hyun Kim, MD,PhD

  Seoul Metropolitan Boramae Hospital

  STUDY DIRECTOR

• Seung-Jea Tahk, MD,PhD

  Ajou University Medical Center

  STUDY DIRECTOR

• Seung-Jae Joo, MD,PhD

  Jeju National University Hospital

  STUDY DIRECTOR

• Young-Jin Choi, MD,PhD

  Hallym University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 25, 2009
• First Posted: July 28, 2009
• Study Start: November 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 13, 2016

Record last verified: 2016-10