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Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence

NCT02126982 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2023-11-28

No results posted yet for this study

Summary

Clopidogrel besylate (CB) is not differentiated relative to the orignal clopidogrel hydrogen sulfate (CHS) in the pharmacokinetics and in antiplatelet potency in healthy volunteers. In addition,CB exhibits similar pharmacodynamic properties compared to CHS in patients with a history of acute coronary syndrome (ACS) and in patients with ACS undergoing percutaneous coronary intervention (PCI). However, there is a lack of data on the clinical efficacy and safety of this salt to the original salt in patients with cardiovascular disease. The aim of this study is to investigate the clinical efficacy and safety of CB in relation to that of CHS in patients eligible to receive clopidogrel.

Conditions

Sponsors & Collaborators

  • University Hospital, Ioannina

    collaborator OTHER

  • University of Ioannina

    lead OTHER

Principal Investigators

  • Alexandros Tselepis, MD, PhD Professor · University of Ioannina

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-05-31
Completion
2014-11-30

Countries

  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02126982 on ClinicalTrials.gov