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Dual Antiplatelet Therapy Tailored on the Extent of Platelet Inhibition (DANTE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Florence.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Tuscany Region
Information provided by:
University of Florence
ClinicalTrials.gov Identifier:
NCT00774475
First received: October 16, 2008
Last updated: October 23, 2008
Last verified: October 2008
History of Changes

October 16, 2008
October 23, 2008
November 2008
November 2010   (final data collection date for primary outcome measure)
Incidence of MACE (cardiovascular death, nonfatal myocardial infarction, target lesion vessel revascularization by PCI or coronary bypass) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00774475 on ClinicalTrials.gov Archive Site
Stent thrombosis with angiographic confirmation; platelet function assessed by VerifyNow P2Y12 1 week after the randomization [ Time Frame: 1 week; 6 and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dual Antiplatelet Therapy Tailored on the Extent of Platelet Inhibition
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

The purpose of this study is to evaluate the efficacy (reduction of major ischemic events at 6 and 12 months of follow-up) of a tailored clopidogrel therapy in patients with UA/NSTEMI undergoing PCI with stent implantation and wiht a documented residual platelet reactivity assessed by a point of care system (VerifyNow P2Y12).

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Unstable Angina
  • NSTEMI
  • Drug: comparison of different dosage of clopidogrel
    clopidogrel 75 mg/day versus clopidogrel 150 mg/day
  • Drug: doubled therapy
    clopidogrel 150 mg/day
  • Placebo Comparator: 1: standard therapy
    clopidogrel 75 mg/day
    Intervention: Drug: comparison of different dosage of clopidogrel
  • Active Comparator: 2: doubled therapy
    clopidogrel 150 mg/day
    Intervention: Drug: doubled therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
442
January 2011
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Unstable or NSTEMI

Exclusion Criteria:

Previous bleeding events which have required blood transfusion

  • 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
Both
20 Years to 90 Years
No
Contact: Gian Franco Gensini, MD 00390557949417 g.gensini@dac.unifi.it
Contact: Rossella Marcucci, MD 00390557949420 rossella.marcucci@unifi.it
Italy
 
NCT00774475
000
No
Gian Franco Gensini, University of Florence
University of Florence
Tuscany Region
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
University of Florence
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP