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Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence (SCIENCE)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 30, 2014
Last Update Posted: December 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
University Hospital, Ioannina
Information provided by (Responsible Party):
Alexandros Tselepis, University of Ioannina
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.

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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparative Study of Clinical Efficacy and Safety of Different Clopidogrel Salts in Patients With Cardiovascular Disease. A Multi-center Non-interventional Clinical Trial.

Resource links provided by NLM:

Further study details as provided by Alexandros Tselepis, University of Ioannina:

Primary Outcome Measures:
  • Primary Efficacy End Point [ Time Frame: 12 months ]
    Composite of death from vascular causes (cardiovascular causes or cerebrovascular causes), MI, or stroke for the entire follow-up period.

Secondary Outcome Measures:
  • Secondary Efficacy End Point [ Time Frame: up to 6 and 12 months ]
    Composite of death from any cause, MI, or stroke (ischemic or hemorrhagic), stent thrombosis and PCI during the entire follow-up period

Other Outcome Measures:
  • Primary Safety End Point [ Time Frame: up to 6 and 12 months ]
    The rate of bleeding events as defined by Bleeding Academic Research Consortium (BARC) criteria

  • Secondary Safety End Point [ Time Frame: up to 6 and 12 months ]
    Urticaria, temporary or permanent interruption of clopidogrel due to urticaria, temporary interruption due to surgery, dental procedures, patient's desire or bleeding, transient thrombocytopenia

Enrollment: 1500
Study Start Date: October 2012
Study Completion Date: November 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Clopidogrel hydrogen sulfate (CHS)
Clopidogrel hydrogen sulfate, 75 mg / day
Clopidogrel Besylate (CB)
Clopidogrel Besylate , 75 mg / day

  Show Detailed Description


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • >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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126982

Atherothrombosis Research Centre / Laboratory of Biochemistry, University of Ioannina
Ioannina, Epirus, Greece, 45110
Sponsors and Collaborators
University of Ioannina
University Hospital, Ioannina
Study Chair: Alexandros Tselepis, MD, PhD Professor University of Ioannina
  More Information

Darius H, Münzel T, Huber K, Sultan E, Walter U. J Kardiol 2009; 16: 412-6.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alexandros Tselepis, Atherothrombosis Research Centre, University of Ioannina
ClinicalTrials.gov Identifier: NCT02126982     History of Changes
Other Study ID Numbers: 2012-Clo-U-Io-01
First Submitted: April 28, 2014
First Posted: April 30, 2014
Last Update Posted: December 16, 2015
Last Verified: December 2015

Keywords provided by Alexandros Tselepis, University of Ioannina:
clopidogrel besylate
clopidogrel hydrogen sulfate
Generic clopidogrel
Coronary Artery Disease

Additional relevant MeSH terms:
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Peripheral Arterial Disease
Carotid Artery Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Peripheral Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs