Acute Coronary Syndrome Clinical Trial
— PRU-MATRIXOfficial title:
Customized Choice of P2Y12 Oral Receptor Blocker Based on Phenotype Assessment Via Point of Care Testing
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.
Status | Recruiting |
Enrollment | 4000 |
Est. completion date | December 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Spedali Civili di Brescia | Brescia | |
Italy | Azienda USL Sirai | Carbonia | |
Italy | Azienda Ospedaliera Pugliese Ciaccio | Catanzaro | Calabria |
Italy | University Hospital of Ferrara | Ferrara | |
Italy | Ospedale di Lodi | Lodi | |
Italy | Azienda Ospedaliera Fatebenefratelli e Oftalmico | Milano | MI |
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 |
Lead Sponsor | Collaborator |
---|---|
Italian Society of Invasive Cardiology | Eustrategy |
Italy,
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. — View Citation
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. Review. — View Citation
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. — View Citation
Valgimigli M, Campo G, de Cesare N, Meliga E, Vranckx P, Furgieri A, Angiolillo DJ, Sabatè 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiovascular death, myocardial infarction, stroke or BARC defined bleeding type 2, 3 or 5 | The time to first occurrence of any of the variables listed above will be reported as primary study outcome. | 1 year | Yes |
Primary | Proportion of patients in the therapeutic range for residual P2Y12 pathway activity according to PRU values. | 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. | 30 days | No |
Secondary | Overall death | 1 | Yes | |
Secondary | cardiovascular death | 1 year | Yes | |
Secondary | myocardial infarction | 1 year | Yes | |
Secondary | stroke | 1 year | Yes | |
Secondary | BARC bleeding type 2 | 1 year | Yes | |
Secondary | BARC bleeding type 3 | 1 year | Yes | |
Secondary | BARC bleeding type 5 | 1 year | Yes | |
Secondary | Bleeding classified according to the Bleedscore | 1 year | Yes | |
Secondary | Stent thrombosis | Stent thrombosis will be reported according to the ARC classification | 1 year | Yes |
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