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Customized Choice of Oral P2Y12 Receptor Blocker (PRU-MATRIX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01477775
Recruitment Status : Unknown
Verified September 2014 by Italian Society of Invasive Cardiology.
Recruitment status was:  Recruiting
First Posted : November 23, 2011
Last Update Posted : September 3, 2014
Sponsor:
Collaborator:
Eustrategy
Information provided by (Responsible Party):
Italian Society of Invasive Cardiology

Study Description
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Brief Summary:
A subset of patients recruited in the main MATRIX study will be randomized after intervention but before discharge to standard of care (the treating physician will decide which oral P2Y12 inhibitor will be added on top of aspirin) versus a customized approach based on an algorithm which integrates phenotypic information, including but not limited to residual on-treatment platelet reactivity assessed via VerifyNow P2Y12 Assay.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Coronary Angioplasty Drug: Oral P2Y12 receptor blocker Drug: Customized choice for the oral P2Y12 receptor blocker Phase 4

Detailed Description:

Up to 20-30% of clopidogrel treated patients do not adequately respond to the drug and are at higher risk for ischemic events including death, myocardial infarction, stroke and stent thrombosis.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Customized Choice of P2Y12 Oral Receptor Blocker Based on Phenotype Assessment Via Point of Care Testing
Study Start Date : January 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Drug: Oral P2Y12 receptor blocker
Free choice among clopidogrel, prasugrel or ticagrelor
Experimental: 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.
 Drug: Customized choice for the oral P2Y12 receptor blocker
one drug among clopidogrel, prasugrel or ticagrelor based on an algorithm integrating phenotype information.


Outcome Measures
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Primary Outcome Measures :
  1. Cardiovascular death, myocardial infarction, stroke or BARC defined bleeding type 2, 3 or 5 [ Time Frame: 1 year ]
    The time to first occurrence of any of the variables listed above will be reported as primary study outcome.

  2. Proportion of patients in the therapeutic range for residual P2Y12 pathway activity according to PRU values. [ Time Frame: 30 days ]
    We expect that the prospective use of the previously generated combined phenotype and genotype algorithm will result in an higher proportion of patients being in the therapeutic range with respect to the P2Y12 residual activity (70%) as compared to patients in who the P2Y12 inhibitor is left to the discretion of the treating physician. The first 320 patients recruited in the present study will participate into this mechanistic sub-study.


Secondary Outcome Measures :
  1. Overall death [ Time Frame: 1 ]
  2. cardiovascular death [ Time Frame: 1 year ]
  3. myocardial infarction [ Time Frame: 1 year ]
  4. stroke [ Time Frame: 1 year ]
  5. BARC bleeding type 2 [ Time Frame: 1 year ]
  6. BARC bleeding type 3 [ Time Frame: 1 year ]
  7. BARC bleeding type 5 [ Time Frame: 1 year ]
  8. Bleeding classified according to the Bleedscore [ Time Frame: 1 year ]
  9. Stent thrombosis [ Time Frame: 1 year ]
    Stent thrombosis will be reported according to the ARC classification


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients recruited in the main MATRIX study who underwent coronary angioplasty with stent placement.

Exclusion Criteria:

  • unwillingness to sign this sub study specific informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477775


Contacts
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Contact: Marco Valgimigli, MD, PhD 3356478877 ext +39 vlgmrc@unife.it
Contact: Maria Salomone, MD 3357378767 ext +39 m.salomone@dimensione-ricerca.com

Locations
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Italy
Azienda Ospedaliera Pugliese Ciaccio Active, not recruiting
Catanzaro, Calabria, Italy, 88100
Azienda Ospedaliera Fatebenefratelli e Oftalmico Recruiting
Milano, MI, Italy, 20121
Contact: B. Cortese, MD    +393347298103    bcortese@gmail.com   
Principal Investigator: Bernardo Cortese, MD         
Spedali Civili di Brescia Active, not recruiting
Brescia, Italy
Azienda USL Sirai Recruiting
Carbonia, Italy
Contact: Salvatore Ierna, MD         
Principal Investigator: Salvatore Ierna, MD         
University Hospital of Ferrara Recruiting
Ferrara, Italy, 44100
Contact: Marco Valgimigli, MD, PhD    3356478877 ext +39    vlgmrc@unife.it   
Principal Investigator: Gianluca Campo, MD         
Ospedale di Lodi Active, not recruiting
Lodi, Italy
Ospedale dei Colli, Cardiologia SUN Recruiting
Naples, Italy
Contact: Paolo Calabrò, MD PhD         
Principal Investigator: Paolo Calabrò, MD         
Ospedale degli Infermi di Rimini Recruiting
Rimini, Italy
Contact: Andrea Santarelli, MD         
Principal Investigator: Andrea Santarelli, MD         
Ospedale San Giovanni Bosco Recruiting
Torino, Italy
Contact: Roberto Garbo, MD         
Principal Investigator: Roberto Garbo, MD         
A. O. Ospedale Civile di Vimercate Recruiting
Vimercate, Italy
Contact: Stefano Garducci, MD         
Principal Investigator: Stefano Garducci, MD         
Policlinico San Marco Recruiting
Zingonia, Italy
Contact: Nicoletta De Cesare, MD         
Principal Investigator: Nicoletta De Casare, MD         
Sponsors and Collaborators
Italian Society of Invasive Cardiology
Eustrategy
Investigators
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Principal Investigator: Marco Valgimigli, MD, PhD University Hospital of Ferrara
More Information
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Publications:

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Responsible Party: Italian Society of Invasive Cardiology
ClinicalTrials.gov Identifier: NCT01477775    
Other Study ID Numbers: RFBU 13-I-PRU
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: September 2014
Keywords provided by Italian Society of Invasive Cardiology:
myocardial infarction
coronary stent
Oral P2Y12 receptor blocker
Platelet reactivity units (PRU)
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases