Dual Antiplatelet Therapy Tailored on the Extent of Platelet Inhibition (DANTE)
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|ClinicalTrials.gov Identifier: NCT00774475|
Recruitment Status : Unknown
Verified October 2008 by University of Florence.
Recruitment status was: Not yet recruiting
First Posted : October 17, 2008
Last Update Posted : October 24, 2008
|Condition or disease||Intervention/treatment||Phase|
|Unstable Angina NSTEMI||Drug: comparison of different dosage of clopidogrel Drug: doubled therapy||Phase 3|
Several studies documented the presence of a high variability in the individual response to antiplatelet therapies in terms of extent of platelet function inhibition. This laboratory finding is the so-called aspirin or clopidogrel resistance which we prefer to define residual platelet reactivity (RPR) on antiplatelet therapy.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||442 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimization of Antiplatelet Therapy With Clopidogrel on the Basis of the Extent of Platelet Inhibition in Patients With Acute Coronary Syndromes on Dual Antiplatelet Therapy Undergoing PCI With Stent Implantation|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||November 2010|
|Estimated Study Completion Date :||January 2011|
Placebo Comparator: 1: standard therapy
clopidogrel 75 mg/day
Drug: comparison of different dosage of clopidogrel
clopidogrel 75 mg/day versus clopidogrel 150 mg/day
Active Comparator: 2: doubled therapy
clopidogrel 150 mg/day
Drug: doubled therapy
clopidogrel 150 mg/day
- Incidence of MACE (cardiovascular death, nonfatal myocardial infarction, target lesion vessel revascularization by PCI or coronary bypass) [ Time Frame: 6 and 12 months ]
- Stent thrombosis with angiographic confirmation; platelet function assessed by VerifyNow P2Y12 1 week after the randomization [ Time Frame: 1 week; 6 and 12 months ]
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): NCT00774475
|Contact: Gian Franco Gensini, MDfirstname.lastname@example.org|
|Contact: Rossella Marcucci, MDemail@example.com|
|University of Florence||Not yet recruiting|
|Florence, Italy, 50134|
|Principal Investigator:||Gian Franco Gensini, MD||University of Florence|
|Study Chair:||Gianni Maria Santoro, MD||ASL 10 Florence, Italy|
|Study Chair:||Niccolò Marchionni, MD||University of Florence|
|Study Chair:||David Antoniucci, MD||Azienda Ospedaliero-Universitaria Careggi|
|Study Chair:||Alfredo Zuppiroli, MD||ASL 10 Florence Italy|
|Study Chair:||Maria Cristina Landini, MD||ASL 10 Florence Italy|
|Study Director:||Rosanna Abbate, MD||University of Florence|