Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
4000 participants
INTERVENTIONAL
2012-01-31
2015-12-31
Brief Summary
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Detailed Description
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Residual high on-treatment platelet reactivity while the patient is on clopidogrel depends on a complex interplay of phenotypic (spontaneous platelet reactivity, inflammatory status, acuity of the clinical presentation, age, renal function) and genetic variables.
Two main Loss of function alleles have been identified: 1) CYP450 2C19\*2 is present in around 25% of the Caucasian population and result in a lower amount of clopidogrel active metabolite. Carriers of 2C19\*2 are at higher risk for death or MI and 2.7 fold increase in the risk of stent thrombosis if treated with conventional clopidogrel; 2) ABCB-1 C carriers have reduced clopidogrel absorption and they have similarly been shown to be at higher risk for ischemic adverse events if treated with clopidogrel. Many investigators have recently shown however, that the positive predictive value of genetic testing alone at the time of PCI is limited and the knowledge of genetic status alone with respect to the two previously described loss of function alleles is only poorly able to identify to long-term clopidogrel poor responders. An Algorithm has therefore been developed, combining phenotype information which has been shown to risk stratify both ischemic and bleeding events up to one year follow-up in PCI patients.
This algorithm has been developed from a single center retrospective registry. To prospectively validate it in the context of a prospective multicenter study, the first 320 patients recruited in the present study will undergo phenotype at discharge and at 30 days and genotype assessment at the time of randomization, irrespective of the group which they have been assigned to (i.e. standard of care or gene and phenotype). The hypothesis behind this mechanistic sub-study is that the use of this combined phenotype-genotype algorithm will increase the proportion of patients at 30 days who will be in the therapeutic range according to PRU values from 50% in the standard of care versus 70% in the gene and phenotype group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care
The treating physician will be left free to give the oral P2Y12 receptor blocker, including clopidogrel,prasugrel or ticagrelor, which according to his/her clinical judgement is most appropriate for the individual patient.
Oral P2Y12 receptor blocker
Free choice among clopidogrel, prasugrel or ticagrelor
Customized choice of the oral P2Y12 receptor blocker
The choice of the oral P2Y12 receptor blocker will be based on an algorithm which integrates phenotype information, including but not limited to residual on-treatment platelet reactivity assessed via Verifynow P2Y12 assay.
Customized choice for the oral P2Y12 receptor blocker
one drug among clopidogrel, prasugrel or ticagrelor based on an algorithm integrating phenotype information.
Interventions
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Oral P2Y12 receptor blocker
Free choice among clopidogrel, prasugrel or ticagrelor
Customized choice for the oral P2Y12 receptor blocker
one drug among clopidogrel, prasugrel or ticagrelor based on an algorithm integrating phenotype information.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Eustrategy
OTHER
Italian Society of Invasive Cardiology
OTHER
Responsible Party
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Principal Investigators
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Marco Valgimigli, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Ferrara
Locations
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Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, Calabria, Italy
University Hospital of Ferrara
Ferrara, Ferrara, Italy
Azienda Ospedaliera Fatebenefratelli e Oftalmico
Milan, MI, Italy
Spedali Civili di Brescia
Brescia, , Italy
Azienda USL Sirai
Carbonia, , Italy
Ospedale di Lodi
Lodi, , Italy
Ospedale dei Colli, Cardiologia SUN
Naples, , Italy
Ospedale degli Infermi di Rimini
Rimini, , Italy
Ospedale San Giovanni Bosco
Torino, , Italy
A. O. Ospedale Civile di Vimercate
Vimercate, , Italy
Policlinico San Marco
Zingonia, , Italy
Countries
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Central Contacts
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Facility Contacts
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Salvatore Ierna, MD
Role: primary
Paolo Calabrò, MD PhD
Role: primary
Andrea Santarelli, MD
Role: primary
Roberto Garbo, MD
Role: primary
Stefano Garducci, MD
Role: primary
Nicoletta De Cesare, MD
Role: primary
References
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Campo G, Parrinello G, Ferraresi P, Lunghi B, Tebaldi M, Miccoli M, Marchesini J, Bernardi F, Ferrari R, Valgimigli M. Prospective evaluation of on-clopidogrel platelet reactivity over time in patients treated with percutaneous coronary intervention relationship with gene polymorphisms and clinical outcome. J Am Coll Cardiol. 2011 Jun 21;57(25):2474-83. doi: 10.1016/j.jacc.2010.12.047.
Campo G, Ferraresi P, Marchesini J, Bernardi F, Valgimigli M. Relationship between paraoxonase Q192R gene polymorphism and on-clopidogrel platelet reactivity over time in patients treated with percutaneous coronary intervention. J Thromb Haemost. 2011 Oct;9(10):2106-8. doi: 10.1111/j.1538-7836.2011.04457.x. No abstract available.
Campo G, Miccoli M, Tebaldi M, Marchesini J, Fileti L, Monti M, Valgimigli M, Ferrari R. Genetic determinants of on-clopidogrel high platelet reactivity. Platelets. 2011;22(6):399-407. doi: 10.3109/09537104.2011.579648. Epub 2011 May 31.
Valgimigli M, Campo G, de Cesare N, Meliga E, Vranckx P, Furgieri A, Angiolillo DJ, Sabate M, Hamon M, Repetto A, Colangelo S, Brugaletta S, Parrinello G, Percoco G, Ferrari R; Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel (3T/2R) Investigators. Intensifying platelet inhibition with tirofiban in poor responders to aspirin, clopidogrel, or both agents undergoing elective coronary intervention: results from the double-blind, prospective, randomized Tailoring Treatment with Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel study. Circulation. 2009 Jun 30;119(25):3215-22. doi: 10.1161/CIRCULATIONAHA.108.833236. Epub 2009 Jun 15.
Other Identifiers
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RFBU 13-I-PRU
Identifier Type: -
Identifier Source: org_study_id
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