Dual Antiplatelet Therapy Tailored on the Extent of Platelet Inhibition
NCT ID: NCT00774475
Last Updated: 2008-10-24
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
PHASE3
442 participants
INTERVENTIONAL
2008-11-30
2011-01-31
Brief Summary
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Detailed Description
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A growing body of evidence is demonstrating the clinical relevance of this laboratory parameter, i.e. patients with RPR are at higher risk of a subsequent adverse cardiovascular event.
In particular, it has been demonstrated that RPR measured by light transmittance aggregometry induced by ADP or by the point of care assay VerifyNow P2Y12 identifies patients which, after coronary revascularization with stent implantation, at higher risk of a potentially catastrophic event such as stent thrombosis.
No randomized trials are available in the literature on the efficacy and safety of an antiplatelet therapy tailored on the extent of platelet function inhibition.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1: standard therapy
clopidogrel 75 mg/day
comparison of different dosage of clopidogrel
clopidogrel 75 mg/day versus clopidogrel 150 mg/day
2: doubled therapy
clopidogrel 150 mg/day
doubled therapy
clopidogrel 150 mg/day
Interventions
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comparison of different dosage of clopidogrel
clopidogrel 75 mg/day versus clopidogrel 150 mg/day
doubled therapy
clopidogrel 150 mg/day
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* PT- INR \>1.5
* Platelet count ≤ 100000/ mm3
* Hb \< 10 g/dl
* Previous TIA/stroke (ischemic or hemorrhagic or unknown)
* Body weight \< 60 Kg
* Creatinine levels ≥ 4 mg/dl
* Cerebral neoplasia
* Recent major trauma/surgery/head injury (within 3 previous weeks)
* Gastrointestinal hemorrhage in the last month
* Aortic dissection
* Known haemorrhagic diathesis
* Oral anticoagulant therapy
* Pregnancy or 1 week after delivery
* Uncontrolled hypertension (systolic \>180 mmHg or diastolic \>110 mmHg)
* Severe liver disease
* Infective endocarditis
* Major psychiatric disorders
* Alcool or drug abuse
* Active peptic ulcer Noncompressible arterial puncture within 14 days Prolonged cardiopulmonary resuscitation
20 Years
90 Years
ALL
No
Sponsors
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Tuscany Region
UNKNOWN
University of Florence
OTHER
Responsible Party
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University of Florence
Principal Investigators
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Gian Franco Gensini, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florence
Gianni Maria Santoro, MD
Role: STUDY_CHAIR
ASL 10 Florence, Italy
Niccolò Marchionni, MD
Role: STUDY_CHAIR
University of Florence
David Antoniucci, MD
Role: STUDY_CHAIR
Azienda Ospedaliero-Universitaria Careggi
Alfredo Zuppiroli, MD
Role: STUDY_CHAIR
ASL 10 Florence Italy
Maria Cristina Landini, MD
Role: STUDY_CHAIR
ASL 10 Florence Italy
Rosanna Abbate, MD
Role: STUDY_DIRECTOR
University of Florence
Locations
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University of Florence
Florence, , Italy
Countries
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Central Contacts
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References
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Gori AM, Marcucci R, Migliorini A, Valenti R, Moschi G, Paniccia R, Buonamici P, Gensini GF, Vergara R, Abbate R, Antoniucci D. Incidence and clinical impact of dual nonresponsiveness to aspirin and clopidogrel in patients with drug-eluting stents. J Am Coll Cardiol. 2008 Aug 26;52(9):734-9. doi: 10.1016/j.jacc.2008.05.032.
Buonamici P, Marcucci R, Migliorini A, Gensini GF, Santini A, Paniccia R, Moschi G, Gori AM, Abbate R, Antoniucci D. Impact of platelet reactivity after clopidogrel administration on drug-eluting stent thrombosis. J Am Coll Cardiol. 2007 Jun 19;49(24):2312-7. doi: 10.1016/j.jacc.2007.01.094. Epub 2007 Jun 4.
Price MJ, Endemann S, Gollapudi RR, Valencia R, Stinis CT, Levisay JP, Ernst A, Sawhney NS, Schatz RA, Teirstein PS. Prognostic significance of post-clopidogrel platelet reactivity assessed by a point-of-care assay on thrombotic events after drug-eluting stent implantation. Eur Heart J. 2008 Apr;29(8):992-1000. doi: 10.1093/eurheartj/ehn046. Epub 2008 Feb 10.
Santoro GM, Carrabba N, Barchielli A, Balzi D, Marchionni N, Filice M, Valente S, Granelli M, Berni I, Buiatti E; AMI-Florence Working Group. Use and efficacy of abciximab in an unselected population with acute myocardial infarction treated with primary angioplasty: data from AMI-Florence registry. Atherosclerosis. 2007 Nov;195(1):116-21. doi: 10.1016/j.atherosclerosis.2006.08.053. Epub 2006 Sep 25.
Balzi D, Barchielli A, Buiatti E, Franceschini C, Lavecchia R, Monami M, Santoro GM, Carrabba N, Margheri M, Olivotto I, Gensini GF, Marchionni N; AMI-Florence Working Group. Effect of comorbidity on coronary reperfusion strategy and long-term mortality after acute myocardial infarction. Am Heart J. 2006 May;151(5):1094-1100. doi: 10.1016/j.ahj.2005.06.037.
Other Identifiers
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000
Identifier Type: -
Identifier Source: org_study_id