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

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Ioannina
Information provided by (Responsible Party):
Alexandros Tselepis, University of Ioannina
ClinicalTrials.gov Identifier:
NCT02126982
First received: April 28, 2014
Last updated: January 8, 2015
Last verified: January 2015
  Purpose

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.


Condition
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 University of Ioannina:

Primary Outcome Measures:
  • Primary Efficacy End Point [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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)
Groups/Cohorts
Clopidogrel hydrogen sulfate (CHS)
Clopidogrel hydrogen sulfate, 75 mg / day
Clopidogrel Besylate (CB)
Clopidogrel Besylate , 75 mg / day

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).

Criteria

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

  • recent treatment with clopidogrel
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02126982

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

Publications:
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
Study First Received: April 28, 2014
Last Updated: January 8, 2015
Health Authority: Greece: National Organization of Medicines

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

Additional relevant MeSH terms:
Acute Coronary Syndrome
Atrial Fibrillation
Carotid Artery Diseases
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Peripheral Arterial Disease
Angina Pectoris
Arrhythmias, Cardiac
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Chest Pain
Heart Diseases
Nervous System Diseases
Pain
Pathologic Processes
Peripheral Vascular Diseases
Signs and Symptoms
Vascular Diseases
Clopidogrel
Ticlopidine
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents

ClinicalTrials.gov processed this record on May 21, 2015