CompletedNot Applicable

Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence

Greece1,500 participantsStarted 2012-10

Plain-language 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.

Who can participate

Age range

18 Years – 84 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Efficacy End Point

Timeframe: 12 months

Trial details

NCT IDNCT02126982

SponsorUniversity of Ioannina

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-05

View on ClinicalTrials.gov More Acute Coronary Syndrome trials