Acute Coronary SyndromeSCIENCENCT02126982
Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence
An observational study of Acute Coronary Syndrome and Coronary Artery Disease, run by University of Ioannina at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Acute Coronary Syndrome, Coronary Artery Disease, Ischemic Stroke
- How many people
- 1,500 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2012to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- >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,
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
Atherothrombosis Research Centre / Laboratory of Biochemistry, University of Ioannina
Ioannina, Epirus, 45110
About this study
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.
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.
Read the detailed description
It is now well documented that platelets play an important role in the pathogenesis of acute coronary syndromes. This phenomenon has significantly strengthened the position of antiplatelet drugs in treatment, and prevention of these syndromes. In terms of administration, antiplatelet drugs are divided into two categories, the oral and intravenous medications. Of these, oral medications are the choice for long-term or prophylactic treatment of patients with acute coronary syndrome. Among them, is clopidogrel, which together with aspirin is now the cornerstone of antiplatelet therapy. Indeed, clopidogrel is a widely used antiplatelet drug. It is second in sales worldwide after atorvastatin and has been prescribed to more than 100 million patients worldwide. Clopidogrel can be used as monotherapy or in combination with aspirin. The efficacy in reducing ischemic events in patients with ACS has been shown in more than 15 major clinical studies involving more than 200,000 patients. These studies also proved the safety of clopidogrel to the bleeding complications (only 1-2% per year).Clopidogrel is a second generation thienopyridine that inhibits the binding of ADP to purinergic receptors of platelet membrane. The ADP activates platelets through different receptors coupled to G-proteins. The main receptor for platelet activation by ADP is P2Y12, associated with the adenyl cyclase and cause deactivation of the resulting reduction in the levels of c-AMP. The identification of this receptor led to the complete elucidation of the mechanism of action of clopidogrel, which proved to be an irreversible antagonist P2Y12.
Clopidogrel is a prodrug that, once granted, is absorbed in the intestine by a process in which an important role is played by the protein carrier ABCB1/MDR1. Then clopidogrel is converted in the liver to the pharmacologically active metabolite by the action of cytochrome P450 (CYP450) and mainly isoform CYP2C19 and isoforms CYP3A4, CYP3A5, CYP1A2, CYP2B6 and CYP2C9. It should be noted that 85% of clopidogrel absorbed, hydrolyzed by esterases in the intestinal mucosa and blood to form biologically inactive products while only 15% of the administered drug is converted to its active metabolite, which is a potent, irreversible, selective inhibitor of receptor P2Y12 ADP resulting in the inhibition of the activation of receptor GPIIb / IIIa and thereby preventing platelet aggregation.
Currently, clopidogrel generic forms are available in the market. Indeed, in 2010 and after 10 years of circulation of the original formulation (clopidogrel bisulfate) under the trade names Plavix or Iscover, released new generic formulations of clopidogrel (generic) due to expiration of the period of exclusive marketing using the original formulation. Main difference of generic forms of clopidogrel to the original formulation (clopidogrel bisulfate) is pharmacochemical recommendation salt of clopidogrel, which in the case of generic formulations is benzenesulfonic (besylate) or hydrochloride salt. Generic formulations of clopidogrel have received marketing approval from the health authorities of the European Union. Bioequivalence comparative studies of clopidogrel generic formulations in healthy volunteers for generic clopidogrel bisulfate, clopidogrel besylate and clopidogrel hydrochloride have proven same pharmacodynamic and pharmacokinetic profile. Considering the wide variability of platelet response to clopidogrel treatment and the high incidence of atherothrombotic events in clopidogrel hyporesponsive patients, studies comparing the pharmacodynamic properties of various generic clopidogrel formulations with those of original clopidogrel bisulfate in CAD patients are essential.
Therefore, given the numerous generic clopidogrel salts that are commercially available today, it is of importance to note that any clinical data or research results arising from the use of these formulations in patients with cardiovascular disease should be related to the specific product used and not generally to the generic clopidogrel.
Our group has performed two prospective pharmacodynamic studies comparing the antiplatelet effectiveness of clopidogrel besylate with that of clopidogrel bisulfate in patients with a history of an ACS, and in ACS patients undergoing PCI. In both studies we showed pharmacodynamic bioequivalence in all platelet function tests performed.
There is a strong need of conducting further clinical studies with adequate number of patients with each clopidogrel generic formulation commercially available in order to confirm its therapeutic equivalence with the innovator product.
- Conditions
- Acute Coronary Syndrome, Coronary Artery Disease, Ischemic Stroke, Peripheral Artery Disease, Carotid Artery Disease, Atrial Fibrillation
- Keywords
- clopidogrel besylate, clopidogrel hydrogen sulfate, Generic clopidogrel, Coronary Artery Disease
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease, Ischemic Stroke, Peripheral Arterial Disease, Carotid Artery Diseases, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel hydrogen sulfate (CHS) | Clopidogrel hydrogen sulfate, 75 mg / day | |
| Clopidogrel Besylate (CB) | Clopidogrel Besylate , 75 mg / day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy End Point
Composite of death from vascular causes (cardiovascular causes or cerebrovascular causes), MI, or stroke for the entire follow-up period.
Measured: 12 months
Secondary outcomes (1)
Secondary Efficacy End Point
Composite of death from any cause, MI, or stroke (ischemic or hemorrhagic), stent thrombosis and PCI during the entire follow-up period
Measured: up to 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ioannina
- Responsible party
- Principal investigator, Alexandros Tselepis, University of Ioannina
- Investigators
- Alexandros Tselepis, MD, PhD Professor, Study chair, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126982
- Sponsor's protocol ID
- 2012-Clo-U-Io-01
- Acronym
- SCIENCE
- Status last verified
- Nov 2023
- First submitted
- 28 Apr 2014
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Davi G, Patrono C. Platelet activation and atherothrombosis. N Engl J Med. 2007 Dec 13;357(24):2482-94. doi: 10.1056/NEJMra071014. No abstract available.
PubMed 18077812Papathanasiou AI, Goudevenos JA, Mikhailidis DP, Tselepis AD. Acute and long-term antiplatelet therapy. Drugs Today (Barc). 2008 May;44(5):331-52. doi: 10.1358/dot.2008.44.5.1215717.
PubMed 18548136Antithrombotic Trialists' Collaboration. BMJ 2002;324;71-86
Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK; Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001 Aug 16;345(7):494-502. doi: 10.1056/NEJMoa010746.
PubMed 11519503Serebruany VL, Malinin AI, Jerome SD, Lowry DR, Morgan AW, Sane DC, Tanguay JF, Steinhubl SR, O'connor CM. Effects of clopidogrel and aspirin combination versus aspirin alone on platelet aggregation and major receptor expression in patients with heart failure: the Plavix Use for Treatment Of Congestive Heart Failure (PLUTO-CHF) trial. Am Heart J. 2003 Oct;146(4):713-20. doi: 10.1016/S0002-8703(03)00260-6.
PubMed 14564328Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK, Malmberg K, Rupprecht H, Zhao F, Chrolavicius S, Copland I, Fox KA; Clopidogrel in Unstable angina to prevent Recurrent Events trial (CURE) Investigators. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet. 2001 Aug 18;358(9281):527-33. doi: 10.1016/s0140-6736(01)05701-4.
PubMed 11520521Sabatine MS, Cannon CP, Gibson CM, Lopez-Sendon JL, Montalescot G, Theroux P, Claeys MJ, Cools F, Hill KA, Skene AM, McCabe CH, Braunwald E; CLARITY-TIMI 28 Investigators. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med. 2005 Mar 24;352(12):1179-89. doi: 10.1056/NEJMoa050522. Epub 2005 Mar 9.
PubMed 15758000Weber AA, Reimann S, Schror K. Specific inhibition of ADP-induced platelet aggregation by clopidogrel in vitro. Br J Pharmacol. 1999 Jan;126(2):415-20. doi: 10.1038/sj.bjp.0702276.
PubMed 10077233Gachet C. ADP receptors of platelets and their inhibition. Thromb Haemost. 2001 Jul;86(1):222-32.
PubMed 11487010Lins R, Broekhuysen J, Necciari J, Deroubaix X. Pharmacokinetic profile of 14C-labeled clopidogrel. Semin Thromb Hemost. 1999;25 Suppl 2:29-33.
PubMed 10440420Gurbel PA, Antonino MJ, Tantry US. Recent developments in clopidogrel pharmacology and their relation to clinical outcomes. Expert Opin Drug Metab Toxicol. 2009 Aug;5(8):989-1004. doi: 10.1517/17425250903107772.
PubMed 19575629Schwarz UR, Geiger J, Walter U, Eigenthaler M. Flow cytometry analysis of intracellular VASP phosphorylation for the assessment of activating and inhibitory signal transduction pathways in human platelets--definition and detection of ticlopidine/clopidogrel effects. Thromb Haemost. 1999 Sep;82(3):1145-52.
PubMed 10494779Darius H, Münzel T, Huber K, Sultan E, Walter U. J Kardiol 2009; 16: 412-6.
Kim SD, Kang W, Lee HW, Park DJ, Ahn JH, Kim MJ, Kim EY, Kim SW, Nam HS, Na HJ, Yoon YR. Bioequivalence and tolerability of two clopidogrel salt preparations, besylate and bisulfate: a randomized, open-label, crossover study in healthy Korean male subjects. Clin Ther. 2009 Apr;31(4):793-803. doi: 10.1016/j.clinthera.2009.04.017.
PubMed 19446152Neubauer H, Kruger JC, Lask S, Endres HG, Pepinghege F, Engelhardt A, Bulut D, Mugge A. Comparing the antiplatelet effect of clopidogrel hydrogensulfate and clopidogrel besylate: a crossover study. Clin Res Cardiol. 2009 Sep;98(9):533-40. doi: 10.1007/s00392-009-0033-1. Epub 2009 Jun 6.
PubMed 19504141
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02126982
- Acronym / sponsor ID
- SCIENCE / 2012-Clo-U-Io-01
- Conditions
- Acute Coronary Syndrome, Coronary Artery Disease, Ischemic Stroke, Peripheral Artery Disease, Carotid Artery Disease, Atrial Fibrillation
- Keywords
- clopidogrel besylate, clopidogrel hydrogen sulfate, Generic clopidogrel, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Collaborators
- University Hospital, Ioannina
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is now well documented that platelets play an important role in the pathogenesis of acute coronary syndromes. This phenomenon has significantly strengthened the position of antiplatelet drugs in treatment, and prevention of these syndromes. In terms of administration, antiplatelet drugs are divided into two categories, the oral and intravenous medications. Of these, oral medications are the choice for long-term or prophylactic treatment of patients with acute coronary syndrome. Among them, is clopidogrel, which together with aspirin is now the cornerstone of antiplatelet therapy. Indeed, clopidogrel is a widely used antiplatelet drug. It is second in sales worldwide after atorvastatin and has been prescribed to more than 100 million patients worldwide. Clopidogrel can be used as monotherapy or in combination with aspirin. The efficacy in reducing ischemic events in patients with ACS has been shown in more than 15 major clinical studies involving more than 200,000 patients. These studies also proved the safety of clopidogrel to the bleeding complications (only 1-2% per year).Clopidogrel is a second generation thienopyridine that inhibits the binding of ADP to purinergic receptors of platelet membrane. The ADP activates platelets through different receptors coupled to G-proteins. The main receptor for platelet activation by ADP is P2Y12, associated with the adenyl cyclase and cause deactivation of the resulting reduction in the levels of c-AMP. The identification of this receptor led to the complete elucidation of the mechanism of action of clopidogrel, which proved to be an irreversible antagonist P2Y12.
Clopidogrel is a prodrug that, once granted, is absorbed in the intestine by a process in which an important role is played by the protein carrier ABCB1/MDR1. Then clopidogrel is converted in the liver to the pharmacologically active metabolite by the action of cytochrome P450 (CYP450) and mainly isoform CYP2C19 and isoforms CYP3A4, CYP3A5, CYP1A2, CYP2B6 and CYP2C9. It should be noted that 85% of clopidogrel absorbed, hydrolyzed by esterases in the intestinal mucosa and blood to form biologically inactive products while only 15% of the administered drug is converted to its active metabolite, which is a potent, irreversible, selective inhibitor of receptor P2Y12 ADP resulting in the inhibition of the activation of receptor GPIIb / IIIa and thereby preventing platelet aggregation.
Currently, clopidogrel generic forms are available in the market. Indeed, in 2010 and after 10 years of circulation of the original formulation (clopidogrel bisulfate) under the trade names Plavix or Iscover, released new generic formulations of clopidogrel (generic) due to expiration of the period of exclusive marketing using the original formulation. Main difference of generic forms of clopidogrel to the original formulation (clopidogrel bisulfate) is pharmacochemical recommendation salt of clopidogrel, which in the case of generic formulations is benzenesulfonic (besylate) or hydrochloride salt. Generic formulations of clopidogrel have received marketing approval from the health authorities of the European Union. Bioequivalence comparative studies of clopidogrel generic formulations in healthy volunteers for generic clopidogrel bisulfate, clopidogrel besylate and clopidogrel hydrochloride have proven same pharmacodynamic and pharmacokinetic profile. Considering the wide variability of platelet response to clopidogrel treatment and the high incidence of atherothrombotic events in clopidogrel hyporesponsive patients, studies comparing the pharmacodynamic properties of various generic clopidogrel formulations with those of original clopidogrel bisulfate in CAD patients are essential.
Therefore, given the numerous generic clopidogrel salts that are commercially available today, it is of importance to note that any clinical data or research results arising from the use of these formulations in patients with cardiovascular disease should be related to the specific product used and not generally to the generic clopidogrel.
Our group has performed two prospective pharmacodynamic studies comparing the antiplatelet effectiveness of clopidogrel besylate with that of clopidogrel bisulfate in patients with a history of an ACS, and in ACS patients undergoing PCI. In both studies we showed pharmacodynamic bioequivalence in all platelet function tests performed.
There is a strong need of conducting further clinical studies with adequate number of patients with each clopidogrel generic formulation commercially available in order to confirm its therapeutic equivalence with the innovator product.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel hydrogen sulfate (CHS) | – | –Clopidogrel hydrogen sulfate, 75 mg / day |
| Clopidogrel Besylate (CB) | – | –Clopidogrel Besylate , 75 mg / day |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- >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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Secondary Efficacy End Point
Time frame: up to 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 18077812Davi G, Patrono C. Platelet activation and atherothrombosis. N Engl J Med. 2007 Dec 13;357(24):2482-94. doi: 10.1056/NEJMra071014. No abstract available.
- Background: PubMed 18548136Papathanasiou AI, Goudevenos JA, Mikhailidis DP, Tselepis AD. Acute and long-term antiplatelet therapy. Drugs Today (Barc). 2008 May;44(5):331-52. doi: 10.1358/dot.2008.44.5.1215717.
- BackgroundAntithrombotic Trialists' Collaboration. BMJ 2002;324;71-86
- Background: PubMed 11519503Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK; Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001 Aug 16;345(7):494-502. doi: 10.1056/NEJMoa010746.
- Background: PubMed 14564328Serebruany VL, Malinin AI, Jerome SD, Lowry DR, Morgan AW, Sane DC, Tanguay JF, Steinhubl SR, O'connor CM. Effects of clopidogrel and aspirin combination versus aspirin alone on platelet aggregation and major receptor expression in patients with heart failure: the Plavix Use for Treatment Of Congestive Heart Failure (PLUTO-CHF) trial. Am Heart J. 2003 Oct;146(4):713-20. doi: 10.1016/S0002-8703(03)00260-6.
- Background: PubMed 11520521Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK, Malmberg K, Rupprecht H, Zhao F, Chrolavicius S, Copland I, Fox KA; Clopidogrel in Unstable angina to prevent Recurrent Events trial (CURE) Investigators. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet. 2001 Aug 18;358(9281):527-33. doi: 10.1016/s0140-6736(01)05701-4.
- Background: PubMed 15758000Sabatine MS, Cannon CP, Gibson CM, Lopez-Sendon JL, Montalescot G, Theroux P, Claeys MJ, Cools F, Hill KA, Skene AM, McCabe CH, Braunwald E; CLARITY-TIMI 28 Investigators. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med. 2005 Mar 24;352(12):1179-89. doi: 10.1056/NEJMoa050522. Epub 2005 Mar 9.
- Background: PubMed 10077233Weber AA, Reimann S, Schror K. Specific inhibition of ADP-induced platelet aggregation by clopidogrel in vitro. Br J Pharmacol. 1999 Jan;126(2):415-20. doi: 10.1038/sj.bjp.0702276.
- Background: PubMed 11487010Gachet C. ADP receptors of platelets and their inhibition. Thromb Haemost. 2001 Jul;86(1):222-32.
- Background: PubMed 10440420Lins R, Broekhuysen J, Necciari J, Deroubaix X. Pharmacokinetic profile of 14C-labeled clopidogrel. Semin Thromb Hemost. 1999;25 Suppl 2:29-33.
- Background: PubMed 19575629Gurbel PA, Antonino MJ, Tantry US. Recent developments in clopidogrel pharmacology and their relation to clinical outcomes. Expert Opin Drug Metab Toxicol. 2009 Aug;5(8):989-1004. doi: 10.1517/17425250903107772.
- Background: PubMed 10494779Schwarz UR, Geiger J, Walter U, Eigenthaler M. Flow cytometry analysis of intracellular VASP phosphorylation for the assessment of activating and inhibitory signal transduction pathways in human platelets--definition and detection of ticlopidine/clopidogrel effects. Thromb Haemost. 1999 Sep;82(3):1145-52.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandros Tselepis, MD, PhD Professor study chair
University of Ioannina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Coronary Artery Disease, run by University of Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy End Point (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02126982, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.