Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence (SCIENCE)
Verified April 2014 by University of Ioannina
Information provided by (Responsible Party):
Alexandros Tselepis, University of Ioannina
First received: April 28, 2014
Last updated: April 29, 2014
Last verified: April 2014
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.
Ischemic Heart Disease
Coronary Heart Disease
Complication of Coronary Artery Bypass Graft
||Time Perspective: Prospective
||Comparative Study of Clinical Efficacy and Safety of Different Clopidogrel Salts in Patients With Cardiovascular Disease. A Multi-center Non-interventional Clinical Trial.
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2014 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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).
- 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
- >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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02126982
|Laboratory of Biochemistry
|Ionnina, Epirus, Greece, 45110 |
|Contact: Alexandros Tselepis, MD, PhD 0030-26510-08365 email@example.com |
University of Ioannina
||Alexandros Tselepis, MD, Professor
||University of Ioannina
||Alexandros Tselepis, Laboratory of Biochemistry, University of Ioannina
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 28, 2014
||April 29, 2014
||Greece: National Organization of Medicines
Keywords provided by University of Ioannina:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Coronary Artery Disease
Arterial Occlusive Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs