Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence

NCT02126982 | Completed

• 1 other identifier: 2012-Clo-U-Io-01
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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

Acute Coronary Syndrome; Coronary Artery Disease; Ischemic Stroke; Peripheral Artery Disease; Carotid Artery Disease; Atrial Fibrillation

Keywords

clopidogrel besylate; clopidogrel hydrogen sulfate; Generic clopidogrel; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy End Point

  Composite of death from vascular causes (cardiovascular causes or cerebrovascular causes), MI, or stroke for the entire follow-up period.

  12 months

Secondary Outcomes (1)

• Secondary Efficacy End Point

  up to 6 and 12 months

Other Outcomes (2)

• Primary Safety End Point

  up to 6 and 12 months

• Secondary Safety End Point

  up to 6 and 12 months

Study Arms (2)

Clopidogrel hydrogen sulfate (CHS)

Clopidogrel hydrogen sulfate, 75 mg / day

Clopidogrel Besylate (CB)

Clopidogrel Besylate , 75 mg / day

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Suitable for the study will be every patient eligible to receive clopidogrel based on the international guidelines. In particular, in the study will participate patients with an acute coronary syndrome (ACS) or having a stable coronary artery disease (CAD). Patients who have experienced an acute ischemic stroke or a transient ischemic attack (TIA) during the previous 6 months or having a history of peripheral artery disease (PAD) or carotid artery disease, will be also eligible for enrollment. Finally, patients with atrial fibrillation (AF) who will refuse or will not be eligible to use of any oral anticoagulant will be included in the study. The study will include at least 1,500 patients (at least 750 will receive clopidogrel hydrogen sulfate and at least 750 clopidogrel besylate).

You may qualify if:

• Both sexes
• age \>18 years
• age \<85 years
• Patients with an ACS with or without percutaneous coronary intervention, stable CAD, history of an ischemic stroke/TIA, PAD, carotid artery disease or atrial fibrillation
• agree on study participation
• will comply with all required study procedures

You may not qualify if:

• \>85 years
• \<18 years
• Patients with
• hypersensitivity reaction or contraindication to clopidogrel,
• active bleeding or history of severe bleeding (peptic ulcer, trauma or intracranial hemorrhage),
• blood coagulation disorders,
• uncontrolled severe hypertension,
• history of drug or alcohol abuse,
• pregnancy or breastfeeding,
• liver disease
• chronic kidney disease,
• malignancy,
• disagree on study participation,
• evidence for poor compliance with all required study procedures

Sponsors & Collaborators

• University of Ioannina: lead
• University Hospital, Ioannina: collaborator

Study Sites (1)

Atherothrombosis Research Centre / Laboratory of Biochemistry, University of Ioannina

Ioannina, Epirus, 45110, Greece

Location

Related Publications (21)

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  BACKGROUND

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• Tsoumani ME, Kalantzi KI, Dimitriou AA, Ntalas IV, Goudevenos IA, Tselepis AD. Antiplatelet efficacy of long-term treatment with clopidogrel besylate in patients with a history of acute coronary syndrome: comparison with clopidogrel hydrogen sulfate. Angiology. 2012 Oct;63(7):547-51. doi: 10.1177/0003319711427697. Epub 2011 Dec 5.

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• Tsoumani ME, Kalantzi KI, Dimitriou AA, Ntalas IV, Goudevenos IA, Tselepis AD. Effect of clopidogrel besylate on platelet reactivity in patients with acute coronary syndromes. Comparison with clopidogrel hydrogen sulfate. Expert Opin Pharmacother. 2012 Feb;13(2):149-58. doi: 10.1517/14656566.2012.644536. Epub 2011 Dec 21.

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• Ntalas IV, Kalantzi KI, Tsoumani ME, Bourdakis A, Charmpas C, Christogiannis Z, Dimoulis N, Draganigos A, Efthimiadis I, Giannakoulas G, Giatrakos I, Giogiakas V, Goumas G, Hatziathanasiou G, Kazakos E, Kipouridis N, Konstantinou S, Milionis H, Nikolopoulos D, Peltekis L, Prokopakis N, Sinteles I, Stroumbis C, Terzoudi K, Thoma M, Tsilias K, Vakalis I, Vardakis K, Vasilakopoulos V, Vemmos K, Voukelatou M, Xaraktsis I, Panagiotakos DB, Goudevenos JA, Tselepis AD. Salts of Clopidogrel: Investigation to Ensure Clinical Equivalence: A 12-Month Randomized Clinical Trial. J Cardiovasc Pharmacol Ther. 2016 Nov;21(6):516-525. doi: 10.1177/1074248416644343. Epub 2016 Apr 14.

  PMID: 27081185 DERIVED

• Ntalas IV, Kalantzi KI, Tsoumani ME, Vakalis JN, Vasilakopoulos V, Vardakis K, Vemmos KN, Voukelatou M, Giannakoulas G, Giatrakos I, Giogiakas V, Goumas G, Dimoulis N, Draganigos A, Efthimiadis I, Thoma M, Kazakos E, Kipouridis N, Konstantinou S, Bourdakis A, Nikolopoulos D, Peltekis L, Prokopakis N, Sinteles I, Stroumbis CS, Terzoudi K, Tsilias K, Xaraktsis I, Charmpas C, Hatziathanasiou G, Christogiannis Z, Panagiotakos DB, Goudevenos JA, Tselepis AD. Generic Clopidogrel Besylate in the Secondary Prevention of Atherothrombotic Events: A 6-month Follow-up of a Randomised Clinical Trial. Curr Vasc Pharmacol. 2015;13(6):809-18. doi: 10.2174/1570161113666150316220515.

  PMID: 25782408 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease; Ischemic Stroke; Peripheral Arterial Disease; Carotid Artery Diseases; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Atherosclerosis; Peripheral Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandros Tselepis, MD, PhD Professor

  University of Ioannina

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Atherothrombosis Research Centre

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: April 30, 2014
• Study Start: October 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

GR (1)