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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Ioannina
Sponsor:
Information provided by (Responsible Party):
Alexandros Tselepis, University of Ioannina
ClinicalTrials.gov Identifier:
NCT02126982
First received: April 28, 2014
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

Clopidogrel besylate differentiated relative to the clopidogrel bisulfate in the pharmacokinetics and in antiplatelet activity in healthy volunteers in patients with a history of acute coronary syndrome (ACS) and in patients with ACS undergoing angioplasty. However there is a lack of data on the clinical efficacy of this salt to the original salt in patients with cardiovascular disease. Therefore in this study will investigate the clinical efficacy and safety of clopidogrel besylate in relation to that of clopidogrel bisulfate in patients with cardiovascular disease.


Condition
Ischemic Heart Disease
Coronary Heart Disease
Angioplasty
Complication of Coronary Artery Bypass Graft
Ischemic Stroke

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:
  • Number of cardiovascular events during clopidogrel therapy [ Time Frame: up to 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of adverse events during clopidogrel therapy [ Time Frame: 0,1,2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: January 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Suitable for the study will be every patient taking clopidogrel for at least 30 days. In particular in the study involving patients with a history of ischemic heart disease (CHD, Angioplasty, CABG), vascular ischemic stroke non cardiac, receiving clopidogrel (bisulfate or besylate) (75 mg daily). The study will include at least 1000 patients (at least 500 will receive clopidogrel bisulfate and at least 500 clopidogrel besylate).

Criteria

Inclusion Criteria:

  • Both sexes
  • age >18 years
  • age <85 years
  • treated at least 30 days with clopidogrel (bisulfate or besylate) (75 mg daily).
  • history of ischemic heart disease (CHD, Angioplasty, CABG), vascular ischemic stroke non cardiac
  • agree on study participation
  • will comply with all required study procedures

Exclusion Criteria:

  • >85 years
  • <18 years
  • treated less than 30 days with clopidogrel (bisulfate or besylate) (75 mg daily).
  • 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

Contacts
Contact: Alexandros Tselepis, MD, PhD 003026510 08365 atselep@uoi.gr

Locations
Greece
Laboratory of Biochemistry Recruiting
Ionnina, Epirus, Greece, 45110
Contact: Alexandros Tselepis, MD, PhD    0030-26510-08365    atselep@uoi.gr   
Sponsors and Collaborators
University of Ioannina
Investigators
Study Chair: Alexandros Tselepis, MD, Professor University of Ioannina
  More Information

Publications:
Responsible Party: Alexandros Tselepis, Laboratory of Biochemistry, 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: April 29, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by University of Ioannina:
clopidogrel besylate
clopidogrel bisulfate

Additional relevant MeSH terms:
Heart Diseases
Ischemia
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014