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Completed

NCT Number: NCT00947843

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

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

aspirin + pregrel (Clopidogrel resinate)

Drug

Other names: Aspirin: Aspirin Protect (Bayer) 100mg, Pregrel: Clopidogrel resinate (CKD Pharmaceutical) 75mg

aspirin + placebo

Drug

aspirin + plavix (Clopidogrel bisulfate)

Drug

Other names: aspirin : Aspirin Protect (Bayer) 100mg, plavix : Clopidogrel bisulfate (Sanofi-Aventis) 75mg

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 (%))

    Time frame: 1 month

Secondary outcomes

  1. Adverse events after study medication

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • CKD Pharmaceutical Limited

Registry information

Official study title

Assessment of the Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents : A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 28, 2009
Registry last updated
Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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